What is Dimetapp

Dimetapp contains the active ingredients Brompheniramine [Antihistamine] and Pseudoephedrine [Nasal decongestant].

Dimetapp Elixir, Liquid, and Syrup medicine is used:

• to treat nose stuffiness.
• to ease allergy signs.

Other Dimetapp brands contain different active ingredients depending on their uses.

What is brompheniramine?

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Brompheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Brompheniramine Important Information

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Before taking Brompheniramine

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• liver or kidney disease;
• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• enlarged prostate or urination problems; or
• if you take potassium.

FDA pregnancy category C: It is not known whether brompheniramine will harm an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Brompheniramine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

What should I avoid while taking brompheniramine?

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of brompheniramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Brompheniramine can decrease sweating and you may be more prone to heat stroke.

Brompheniramine side effects

Side effects of brompheniramine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.
• Dry mouth.
• Dry nose.

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• difficult breathing;
• swelling of your face, lips, tongue, or throat.

Stop using brompheniramine and call your doctor at once if you have a serious side effect such as:

• fast or uneven heart rate;
• mood changes;
• tremor, seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• feeling short of breath; or
• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;
• dry mouth, nose, or throat;
• constipation;
• blurred vision; or
• feeling nervous or restless.

Nervous system

Nervous system side effects have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine.

A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.

Gastrointestinal

Gastrointestinal side effects have include nausea, dry mouth and constipation.

Cardiovascular

Cardiovascular effects of brompheniramine have included hypotension, tachycardia, and palpitations.

Ocular

Ocular side effects have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.

Hematologic

Hematologic side effects have included rare cases of hemolytic anemia, thrombocytopenia, and agranulocytosis.

What are some side effects that I need to call my doctor about right away?

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug.

Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Change in balance.
• Change in eyesight.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Very bad sore throat.
• Fever or chills.
• Trouble passing urine.
• Any unexplained bruising or bleeding.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Feeling confused.
• Restlessness.
• Shakiness.
• Seizures.

What is pseudoephedrine?

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian tubes.

Pseudoephedrine Important information

Do not give pseudoephedrine to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine if you have used a MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking pseudoephedrine

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• heart disease or high blood pressure;
• diabetes; or
• a thyroid disorder.
• Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

FDA pregnancy category C: It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use pseudoephedrine without telling your doctor if you are breast-feeding a baby.

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

Pseudoephedrine Pregnancy and Breastfeeding Warnings

Pseudoephedrine Pregnancy Warnings

Doses of 35 to 50 times the human daily dose to rabbits and rats, respectively, have not produced teratogenic effects. A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester use in 76 cases. The authors hypothesized vascular disruption as the etiology of gastroschisis. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to this drug were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980 through 1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. There are no adequate and well controlled studies in pregnant women.

Pseudoephedrine Breastfeeding Warnings

Based on limited data, it has been estimated that 0.5% to 0.7% of the mother’s dose is excreted into breast milk over 24 hours. In 1 study, irritability was reported in up to 20% of infants. A 24% mean decrease in milk production was observed after a single 60 mg dose in 8 nursing mothers.

Caution is recommended

Excreted into human milk: Yes

Comments:

• Single doses are unlikely to harm a nursing infant, but may cause irritability or disturbed sleep.
• Repeated doses may interfere with lactation in mothers who are having difficulties producing sufficient milk or in those whose lactation is not well established.

What should I avoid whilst taking pseudoephedrine?

Avoid taking pseudoephedrine if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

Pseudoephedrine side effects

Some side effects of pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

The most commonly reported adverse effects have included cardiovascular and (e.g. elevated blood pressure, tachycardia, or arrhythmias), CNS stimulation (e.g. restlessness, insomnia, anxiety, tremors, and rarely hallucinations), skin rashes, and urinary retention.

More common side effects:

• nervousness
• restlessness
• trouble in sleeping

Less common side effects:

• difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

Cardiovascular

• Frequency not reported: Tachycardia, palpitations, arrhythmia, hypertension, impaired circulation to the extremities

Nervous system

• Frequency not reported: Headache, tremor

Gastrointestinal

• Frequency not reported: Dry mouth, nausea, vomiting

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions including cross-sensitivity with other sympathomimetic

Psychiatric

• Rare (less than 0.1%): Hallucinations
• Frequency not reported: Restlessness, insomnia, sleep disturbances, anxiety, excitability

Genitourinary

• Frequency not reported: Urinary retention, especially in men with prostatic enlargement

Ocular

• Frequency not reported: Angle-closure glaucoma

Dermatologic

• Frequency not reported: Skin rashes, fixed drug eruption in the form of erythematous nodular patches

Other side effects

• Post marketing reports: False-positive amphetamine immunoassay
• False-positives can occur far below the published threshold indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.

Get emergency medical help if you have any of these signs of an allergic reaction to pseudoephedrine:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;
• severe dizziness or anxiety;
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious pseudoephedrine side effects may include:

• loss of appetite;
• warmth, tingling, or redness under your skin;
• feeling restless or excited (especially in children);
• sleep problems (insomnia); or
• skin rash or itching.

Check with your doctor as soon as possible if any of the following side effects occur while taking pseudoephedrine:

Rare side effects – more common with high doses:

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of pseudoephedrine overdose:

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

What do I need to tell my doctor before I take Dimetapp?

• If you have an allergy to brompheniramine, pseudoephedrine, or any other part of Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dimetapp?

• Tell all of your health care providers that you take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup). This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) affects you.
• Avoid drinking alcohol while taking Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Dimetapp best taken?

Use Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Measure liquid doses carefully. Use the measuring device that comes with Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup). If there is none, ask the pharmacist for a device to measure Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).

What do I do if I miss a dose?

• If you take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Dimetapp?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

If Dimetapp OVERDOSE is suspected

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Dimetapp Formula Finder

Children’s Dimetapp Cold and Allergy

• Active ingredients (in each 10 ml): Brompheniramine maleate USP 2 mg [Antihistamine] + Phenylephrine HCl USP 5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 6 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Cold and Allergy Uses:

• Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Cold and Allergy Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema, asthma, or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Cold and Allergy Directions of Use

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 1. Children’s Dimetapp Cold and Allergy Dosage Chart

Children’s Dimetapp Cold and Cough

• Active ingredients (in each 10 ml): Brompheniramine maleate USP 2 mg [Antihistamine] + Phenylephrine HCl USP 5 mg [Nasal decongestant] + Dextromethorphan HBr, USP 10 mg [Cough suppressant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 6 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Cold and Cough Uses:

• Temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Cold and Cough Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Cold and Cough Directions of Use

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 2. Children’s Dimetapp Cold and Cough Dosage Chart

Children’s Dimetapp Long Acting Cough Plus Cold

• Active ingredients (in each 5 ml teaspoon): Chlorpheniramine maleate, USP 1.0 mg [Antihistamine] + Dextromethorphan HBr, USP 7.5 mg [Cough suppressant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each teaspoon contains: sodium 3 mg
• store at 20-25°C (68-77°F)
• dosage cup provided

Children’s Dimetapp Long Acting Cough Plus Cold Uses:

• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Children’s Dimetapp Long Acting Cough Plus Cold Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Long Acting Cough Plus Cold Directions of Use

• do not take more than 4 doses in any 24-hour period
• ml = milliliter

Table 3. Children’s Dimetapp Long Acting Cough Plus Cold Dosage Chart

Children’s Dimetapp Multi-Symptom Cold and Flu

• Active ingredients (in each 10 ml): Acetaminophen, USP 320 mg [Pain reliever & Fever reducer] + Diphenhydramine HCl, USP 12.5 mg [Antihistamine & Cough suppressant] + Phenylephrine HCl, USP 5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 7 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Multi-Symptom Cold and Flu Uses:

• Temporarily relieves these symptoms associated with a cold, or flu:
  • headache
  • sore throat
  • fever
  • minor aches and pains
• Temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Multi-Symptom Cold and Flu Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if user takes

• more than 5 doses in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do NOT use

• to sedate a child or to make a child sleepy
• in a child under 6 years of age
• if user is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if user has:

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is:

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• user gets nervous, dizzy, or sleepless
• pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Children’s Dimetapp Multi-Symptom Cold and Flu Directions of Use

• do not take more than 5 doses in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 4. Children’s Dimetapp Multi-Symptom Cold and Flu Dosage Chart

Children’s Dimetapp Nighttime Cold and Congestion

• Active ingredients (in each 5 ml teaspoon): Diphenhydramine HCl, USP 6.25 mg [Antihistamine & Cough suppressant] + Phenylephrine HCl, USP 2.5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each teaspoon contains: sodium 4 mg
• dosage cup provided
• store at 20-25°C (68-77°F)

Children’s Dimetapp Nighttime Cold and Congestion Uses:

• Temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
  • cough

Children’s Dimetapp Nighttime Cold and Congestion Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Nighttime Cold and Congestion Directions of Use

• do not take more than 6 doses in any 24-hour period
• do not exceed recommended dosage
• ml = milliliter

Table 5. Children’s Dimetapp Nighttime Cold and Congestion Dosage Chart

Dimetapp Elixir

• Active ingredients (in each 5 ml teaspoon): Brompheniramine maleate, USP 1 mg [Antihistamine] + Pseudoephedrine HCl, USP 15 mg [Nasal decongestant]
• Inactive ingredients: artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

Other information

• store at 20-25°C (68-77°F)
• not a United States Pharmacopeia (USP) elixir
• dosage cup provided
• Pleasant tasting – children find its great grape taste easy to take.
• Adults like it, too – especially those who have difficulty swallowing tablets or capsules.

Dimetapp Elixir Uses:

• Temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Dimetapp Elixir Warnings

Do NOT use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dimetapp Elixir Directions of Use

• do not take more than 4 doses in any 24-hour period
• ml = milliliter

Table 6. Dimetapp Elixir Dosage Chart

Dimetapp Pediatric Elixir

• Active ingredients (in each 5 ml teaspoon): Brompheniramine maleate, USP 1 mg [Antihistamine] + Pseudoephedrine HCl, USP 15 mg [Nasal decongestant]
• Inactive ingredients: artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

Other information

• store at 20-25°C (68-77°F)
• not a United States Pharmacopeia (USP) elixir
• dosage cup provided

Dimetapp Pediatric Elixir Uses:

• Temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Dimetapp Pediatric Elixir Warnings

Do NOT use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dimetapp Pediatric Elixir Directions of Use

• do not exceed recommended dosage
• ml = milliliter

Table 7. Dimetapp Pediatric Elixir Dosage Chart

What is Excedrin-Migraine

Excedrin-Migraine is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin-Migraine is used to treat migraine headaches.

Interestingly, the products sold as Excedrin, Excedrin Menstrual and Excedrin Tension Headache contain identical active ingredients even though advertised for different conditions!

• If Excedrin-Migraine isn’t effectively controlling your migraines, your doctor may refer you to a specialist migraine clinic for further investigation and treatment. A specialist may recommend other treatments such as transcranial magnetic stimulation.
• Transcranial magnetic stimulation involves holding a small electrical device to your head that delivers magnetic pulses through your skin. It’s not clear exactly how transcranial magnetic stimulation works in treating migraines, but studies have shown that using it at the start of a migraine can reduce its severity. It can also be used in combination with the medications mentioned above without interfering with them. However, transcranial magnetic stimulation isn’t a cure for migraines and it doesn’t work for everyone. The evidence for its effectiveness isn’t strong and is limited to people who have migraine with aura. There’s also little evidence about the potential long-term effects of the treatment, although studies into the treatment have so far only reported minor and temporary side effects, including:
  • slight dizziness
  • drowsiness and tiredness
  • a muscle tremor that can make it difficult to stand
  • irritability

Excedrin-Migraine ingredients

The active ingredients in Excedrin-Migraine are Acetaminophen 250 mg + Aspirin 250 mg + Caffeine 65 mg.

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Aspirin

Aspirin is also known as acetylsalicylic acid in a class of drug called nonsteroidal anti-inflammatory drugs (NSAIDs) that is similar to non-steroidal inflammatory (NSAIDs) like Ibuprofen (Motrin or Advil) and naproxen (Aleve). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation.

Aspirin can prevent the formation of blood clots which can make it useful in treating or preventing some conditions like heart attacks and strokes. The dosage for aspirin can range from 50 to 6000 milligrams (mg) per day depending on the condition being treated, and aspirin may be used in combination with other medications.

Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina).

Aspirin is a common medicine that has a number of uses, from relieving pain to reducing the risk of serious problems such as heart attacks and strokes.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin-Migraine.

Aspirin can be used to treat:

• Mild to moderate pain
• Fever
• Swollen, red and tender body tissues
• Rheumatoid arthritis
• Rheumatic fever ¹

It is also used in the prevention of blood clots, heart attacks, strokes and bowel cancer ¹.

Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Uses for aspirin

At high doses – usually 300mg – aspirin can relieve pain, reduce a high temperature (fever) and reduce swelling.

Aspirin is often used for short-term relief from:

• headaches and migraines
• toothache
• period pains
• general aches and pains
• colds and flu

Long-term treatment with low doses of aspirin – usually 75mg – has an antiplatelet effect, which means it makes the blood less sticky and can stop blood clots developing.

A doctor may recommend low doses of aspirin (75mg) if you have or have had:

• a heart attack or angina
• a stroke or transient ischemic attack (TIA)
• peripheral arterial disease
• coronary artery bypass surgery or another operation on your heart or blood vessels

Aspirin may also be prescribed for children after heart surgery or to treat Kawasaki disease. But it shouldn’t be given to anyone under 16 years old without medical supervision.

Who can and can’t take Aspirin

Most people can take aspirin safely. But you should get advice from a pharmacist or doctor before taking it if you:

• have had an allergic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, in the past
• have asthma
• have had stomach ulcers in the past
• have severe liver or kidney problems
• have hemophilia or another bleeding disorder
• have uncontrolled high blood pressure
• are looking for medication for a child under 16 – medication containing aspirin shouldn’t be given to children under 16
• are over 65 years of age
• are pregnant, breastfeeding or trying to get pregnant
• are taking other medications

You may still be able to take aspirin in these cases, but you should only do so if advised that it’s safe by a healthcare professional.

If you can’t take aspirin, a different medicine, such as paracetamol (for pain) or clopidogrel (to prevent blood clots), may be recommended instead.

Before taking aspirin

• tell your doctor and pharmacist if you are allergic to aspirin, other medications for pain or fever, tartrazine dye, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants (‘blood thinners’) such as warfarin (Coumadin) and heparin; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics (‘water pills’); medications for diabetes or arthritis; medications for gout such as probenecid and sulfinpyrazone (Anturane); methotrexate (Trexall); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• if you are taking aspirin on a regular basis to prevent heart attack or stroke, do not take ibuprofen (Advil, Motrin) to treat pain or fever without talking to your doctor. Your doctor will probably tell you to allow some time to pass between taking your daily dose of aspirin and taking a dose of ibuprofen.
  tell your doctor if you have or have ever had asthma, frequent stuffed or runny nose, or nasal polyps (growths on the linings of the nose). If you have these conditions, there is a risk that you will have an allergic reaction to aspirin. Your doctor may tell you that you should not take aspirin.
• tell your doctor if you often have heartburn, upset stomach, or stomach pain and if you have or have ever had ulcers, anemia, bleeding problems such as hemophilia, or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking aspirin, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin.
• if you drink three or more alcoholic drinks every day, ask your doctor if you should take aspirin or other medications for pain and fever.

How to take aspirin

Your pharmacist or doctor can tell you how often to take your aspirin and how much you should take. You can also check the recommendations in the leaflet that comes with your medicine.

Generally speaking:

• high-dose aspirin (to relieve pain) can be taken three or four times a day, with at least four hours between each dose, until your symptoms improve
• low-dose aspirin (to prevent blood clots) is taken once a day, usually for the rest of your life

Some medicine leaflets advise taking aspirin with water, while others may recommend taking it before or after food.

Follow the instructions in the leaflet or label that comes with your medicine. Ask your pharmacist if you’re not sure.

Aspirin interactions with other medicines, food and alcohol

Aspirin can potentially interact with other medications, including some complementary and herbal medicines, which could alter their effects or increase your risk of side effects.

Medicines that can interact with aspirin include:

• NSAIDs – such as ibuprofen or naproxen
• steroid medication – such as prednisolone
• anticoagulant medicines – such as warfarin or heparin
• SSRI antidepressants – such as citalopram, fluoxetine or paroxetine
• some medications used to treat high blood pressure – such as ACE inhibitors or diuretics
• some medicines used to treat epilepsy – such as phenytoin
• other medicines containing aspirin – including cold and flu remedies where aspirin is one of the ingredients

Taking aspirin with warfarin (anticoagulant medicine or blood thinner) or some blood pressure medicines may increase the risk of bleeding.

This is not a complete list. If you want to check whether a medicine is safe to take with aspirin, ask your doctor or pharmacist, or read the leaflet that comes with the medicine.

There are no known interactions between aspirin and food.

The risk of bleeding in the stomach may be higher if you drink alcohol while taking aspirin, so you may want to consider reducing how much you drink or avoiding alcohol completely.

Side effects of aspirin

Like all medications, there’s a risk of side effects from aspirin.

The most common side effects are:

• Indigestion and stomach aches – taking your medicine with food may help reduce this risk
• Bleeding or bruising more easily than normal

Other side effects of aspirin:

• Dizziness, ringing in the ears, blurred vision
• Drowsiness, fatigue, depression
• Thirst, sweating, fluid retention, swollen ankles
• Abdominal discomfort or bloating
• Nausea, heartburn, diarrhea, constipation

Uncommon and rare side effects include:

• hives – a raised, itchy rash
• tinnitus – hearing sounds that come from inside your body
• breathing difficulties or an asthma attack
• an allergic reaction – this can cause breathing problems, swelling of the mouth, lips or throat, and a sudden rash
• bleeding in the stomach – this can cause dark, tar-like stools or vomiting blood
• bleeding in the brain – this can cause a sudden, severe headache, vision problems and stroke symptoms, such as slurred speech and weakness on one side of the body

Long-term effects of taking aspirin:

Regular use of aspirin may eventually cause the following effects. It’s best to discuss the side effects of long term use with a medical practitioner.

• Anemia (low red blood cell count)
• Easy bruising and abnormal bleeding
• Inflamed stomach lining, stomach bleeding and peptic ulcers
• Vomiting blood that may look like coffee grounds and bowel motions that look like black tar
• An allergic-type reaction, wheezy breathing and a tightness in the chest in adults, hives in children, and in some rare cases swelling of the face, lips, tongue or around the eyes
• Reduced kidney and liver function

Speak to your doctor if you experience any concerning or troublesome side effects while taking aspirin.

Call your emergency number for an ambulance or go to your nearest accident and emergency (A&E) department if you think you’re having a severe allergic reaction, or you have symptoms of bleeding in your stomach or brain.

Aspirin Overdose

If the dose is too high, you might overdose. If you have any of these symptoms, call an ambulance straight away by dialing your local emergency number.

• Headaches
• Confusion
• Fever
• Deafness
• Vomiting
• Rapid and shallow breathing
• Seizures
• Stop breathing, coma and death
• Burning pain in the throat or stomach
• Decreased urination
• Restlessness
• Irritability
• Talking a lot and saying things that do not make sense
• Fear or nervousness
• Dizziness
• Double vision
• Uncontrollable shaking of a part of the body
• Abnormally excited mood
• Hallucination (seeing things or hearing voices that are not there)
• Drowsiness
• Loss of consciousness for a period of time

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Excedrin-Migraine = 130mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ³

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ⁴.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁵

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁶

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁷

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁵.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁸.

How much caffeine in Excedrin-Migraine

• Excedrin-Migraine: Acetaminophen 250mg + Caffeine 65 mg + Aspirin 250mg
• Excedrin Tension Headache: Acetaminophen 500mg + Caffeine 65 mg
• Excedrin Extra Strength: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Taking Excedrin-Migraine with other painkillers

It’s safe to take Excedrin-Migraine with acetaminophen or codeine.

But don’t take Excedrin-Migraine with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Excedrin-Migraine, aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Excedrin-Migraine plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Excedrin-Migraine

For treating migraine, an alternative to Excedrin-Migraine is acetaminophen (Tylenol).

For migraine pain, ask your doctor or pharmacist for an alternative if Excedrin-Migraine is not suitable for you. Your health professional may suggest you try:

• Acetaminophen (paracetamol)
• Another medicine from the NSAID family
• A medicine that combines codeine with acetaminophen in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever or recommend another treatment, such as triptans or ergots.

Ergotamine and caffeine combination drugs (Migergot, Cafergot) are less effective than triptans. Ergots seem most effective in those whose pain lasts for more than 48 hours. Ergots are most effective when taken soon after migraine symptoms start.

Ergotamine may worsen nausea and vomiting related to your migraines, and it may also lead to medication-overuse headaches.

Dihydroergotamine (D.H.E. 45, Migranal) is an ergot derivative that is more effective and has fewer side effects than ergotamine. It’s also less likely to lead to medication-overuse headaches. It’s available as a nasal spray and in injection form.

Treating migraine without medicine

The following non-medicine treatments may help you to prevent frequent or troublesome migraines — you can use them either instead of, or as well as, medicine treatments:

• physical therapies (e.g., physiotherapy or chiropractic treatment), especially if neck problems are thought to be contributing to your migraines — it’s essential to seek out a therapist with specialist training in this area, however, as there have been very rare reports of stroke after spinal manipulation of the neck
• physical exercise
• relaxation training (e.g., yoga, meditation), which can help manage underlying problems with stress
• cognitive behavioral therapy (CBT), a psychological therapy that teaches you to identify and challenge stress generating thoughts
• acupuncture. If medication is unsuitable, or it doesn’t help to prevent migraines, you may want to consider acupuncture.

Medicines for an acute migraine attack

There’s currently no cure for migraines, although a number of treatments are available to help ease the symptoms.

Most people find that sleeping or lying in a darkened room is the best thing to do when having a migraine attack.

Others find that eating something helps, or they start to feel better once they’ve been sick.

It may take time to work out the best treatment for you. You may need to try different types or combinations of medicines before you find the most effective ones.

Doctors recommend a stepped approach to treatment for acute migraine attack; that is, trying the simplest remedy first. If this fails to manage your pain — as a general rule on 3 consecutive occasions — then you should try the next treatment.

• Step 1. Simple pain relief medicine alone

Most simple pain relief medicines are available to buy over-the-counter in pharmacies and supermarkets.

Many people who have migraines find that over-the-counter painkillers, such as acetaminophen (Tylenol), aspirin and ibuprofen (Advil, Advil-Migraine or Motrin IB), can help to reduce their symptoms.

They tend to be most effective if taken at the first signs of a migraine attack, as this gives them time to absorb into your bloodstream and ease your symptoms.

It’s not advisable to wait until the headache worsens before taking painkillers as it’s often too late for the medication to work. Soluble painkillers (tablets you dissolve in a glass of water) like Advil-Migraine are a good alternative because they’re absorbed quickly by your body.

If you can’t swallow painkillers because of nausea or vomiting, suppositories may be a better option. These are capsules that are inserted into the anus (back passage).

Take pain relief medicine at the first sign of migraine symptoms. As a migraine progresses, your stomach emptying can slow and this can affect the absorption of pain relievers into your bloodstream, making them less effective. This is especially important if you experience nausea and vomiting with migraine.

• Step 2. Simple pain reliever and medicine for nausea and vomiting

If nausea is a problem, or if a pain reliever alone does not relieve your migraine pain, you can take the pain reliever with medicine to treat nausea and vomiting.

Medication for nausea is usually combined with other medications. Frequently prescribed medications are chlorpromazine, metoclopramide (Reglan) or prochlorperazine (Compro).

• Step 3. Anti-migraine medicine: the triptans

If you find you can’t manage your migraines using over-the-counter medicines, your doctor may prescribe something stronger.

Triptans work differently to pain relievers. Triptan medicines are a specific painkiller for migraine headaches. There are a number of different triptans available in the US and you will need to get a prescription from your doctor.

Triptans are thought to work by reversing the changes in the brain that may cause migraine headaches.

They cause the blood vessels around the brain to contract (narrow). This reverses the dilating (widening) of blood vessels that’s believed to be part of the migraine process.

Triptans are available as tablets, injections and nasal sprays.

Common side effects of triptans include:

• warm-sensations
• tightness
• tingling
• flushing
• feelings of heaviness in the face, limbs or chest

Some people also experience nausea, dry mouth and drowsiness. These side effects are usually mild and improve on their own.

As with other painkillers, taking too many triptans can lead to medication overuse headache.

Your doctor will usually recommend having a follow-up appointment once you’ve finished your first course of treatment with triptans. This is so you can discuss their effectiveness and whether you had any side effects.

If the medication was helpful, treatment will usually be continued. If they weren’t effective or caused unpleasant side effects, your doctor may try prescribing a different type of triptan since responses can be highly variable.

• Step 4. Preventive therapy

If you are experiencing two or more severe migraine attacks a month, you could be a candidate for preventive therapy. Preventive therapy is used in addition to treatments for acute attack, not in place of it.

The aim of migraine preventive therapy is to reduce the number of attacks to a manageable level, either because:

• the medicines used to treat attacks don’t control your symptoms adequately, or
• migraine attacks, even though well controlled, are happening far too often, placing you at risk of developing medication overuse headache.

Note that it may take some months for the full effect of preventive therapy to be seen.

In general, medicines used as preventive therapy are more commonly prescribed for the treatment of other conditions (eg, high blood pressure or depression) but have unrelated anti-migraine effects — for example:

• beta-blockers — Propranolol (Deralin), atenolol (Noten, Anselol), metoprolol (Betaloc, Lopressor)
• amitriptyline (Endep).

Other medicines occasionally used to prevent migraines include antiepileptic medicines (especially sodium valproate [Epilim, Valpro] and topiramate [Epiramax, Tamate]), methysergide (Deseril) and botulinum toxin (botox).

Treatment can be complicated and is best managed by a specialist (neurologist).

Excedrin-Migraine Important Information

Do not give Excedrin-Migraine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

Do not take more Excedrin-Migraine than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Excedrin-Migraine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Excedrin-Migraine Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity ⁹.

Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women ¹⁰, ¹¹. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women ¹⁰. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women ¹².

One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women ¹³. That study also suggested that acetaminophen does not affect thromboxane production.

The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs ¹⁴.

Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery ¹⁵, ¹⁶, ¹⁷. Prolonged gestation and labor have been reported due to aspirin’s inhibition of prostaglandin.

A study ¹⁸ of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy–CLASP) did “not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR.” In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

Another study ¹⁹ of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that “low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.”

High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported ¹⁹, ¹⁵. However, a case control study of aspirin use in the first trimester concluded that aspirin “does not increase the risk of congenital heart defects in relation to that of other structural malformations”.

In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Aspirin has been assigned to pregnancy category C by the FDA. However, aspirin is considered to be in pregnancy category D by the FDA if full dose aspirin is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects.

Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations.

Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. During the first two trimesters of pregnancy, the combination of acetaminophen, aspirin, and caffeine should only be given during pregnancy when clearly needed and when benefit outweighs risk. Because of the aspirin component of this combination drug, during the last trimester of pregnancy, this combination product is only recommended for use when there are no alternatives and benefits outweigh risk.

Excedrin-Migraine Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose ²⁰.

Aspirin is excreted into human milk in small amounts ²¹, ²². Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics ²³ characterizes aspirin as a drug that has been “associated with significant effects on some nursing infants and should be given to nursing mothers with caution.”

Acetaminophen is excreted into human milk in small concentrations ²¹. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics.

Caffeine is excreted into human milk in small amounts ²⁴. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

Before taking Excedrin-Migraine Precautions

Do not give Excedrin-Migraine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin-Migraine if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin-Migraine.

Ask a doctor or pharmacist if it is safe for you to take Excedrin-Migraine if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• asthma or seasonal allergies;
• fever with a stiff neck;
• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;
• a bleeding or blood clotting disorder such as hemophilia;
• kidney disease; or
• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin-Migraine to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;
• a headache that causes vomiting;
• what feels like the worst headache you’ve ever had;
• a headache that seems different from your usual headaches;
• a headache every day;
• a headache after coughing, bending, exercising, or head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin-Migraine.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin-Migraine.

How should I take Excedrin-Migraine?

Use Excedrin-Migraine exactly as directed on the label, or as it has been prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Take Excedrin-Migraine with food or milk if it makes your stomach upset.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin-Migraine.

If you need surgery, tell the surgeon ahead of time that you are using Excedrin-Migraine. You may need to stop using the medicine for a short time.

Store Excedrin-Migraine at room temperature away from moisture and heat.

What should I avoid?

Avoid drinking alcohol while you are taking Excedrin-Migraine. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, menstrual symptom, or fever medication. Acetaminophen (paracetamol) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Aspirin and caffeine are also contained in many combination medicines. Check the label to see if a medicine contains acetaminophen (paracetamol), aspirin, or caffeine.

Avoid taking another NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking Excedrin-Migraine. They can add to the side effects of the caffeine in the medication.

What happens if I miss a dose?

Since Excedrin-Migraine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Excedrin-Migraine dosage

Excedrin Migraine Caplets or Geltabs

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin migraine Migraine uses:

• Treats Migraines
  

Excedrin migraine Migraine Directions of Use:

• Do not use more than directed. If symptoms persist or worsen, ask your doctor
• Drink a full glass of water with each dose
• Adults: Take 2 caplets with a glass of water. Do not take more than 2 caplets in 24 hours, unless directed by a doctor.
• Under 18 years of age: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin-Migraine Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Medication overuse headache warning

Headaches may worsen if this product is used for 10 or more days per month.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Ask a doctor before use if:

• you have never had migraines diagnosed by a health professional
• you have a headache that is different from your usual migraines
• you have the worst headache of your life
• you have fever and stiff neck
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
• you experienced your first headache after the age of 50
• you have daily headaches
• you have a migraine so severe as to require bed rest
• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have vomiting with your migraine headache

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 2 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• your migraine is not relieved or worsens after first dose
• ringing in the ears or loss of hearing occurs
• any new or unexpected symptoms occur

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Excedrin-Migraine side effects

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate premenstrual syndrome (PMS).

In general, many side effects noted with aspirin use are dose-related.

Common Excedrin-Migraine side effects may include:

• upset stomach, heartburn;
• depressed mood, feeling anxious or restless; or
• sleep problems (insomnia).

Excedrin-Migraine serious side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Excedrin-Migraine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Excedrin-Migraine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using Excedrin-Migraine and call your doctor at once if you have:

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;
• symptoms of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• high potassium–slow heart rate, weak pulse, muscle weakness, tingly feeling; or
• liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling confused.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Ringing in ears.
• Hearing loss.
• Very bad headache or if headache is not better after the first dose.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad stomach ulcers or bleeding can happen with this drug. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking this drug with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

Other side effects of Excedrin-Migraine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hepatic side effects including hepatotoxicity and hepatitis have been reported.

In alcoholic patients, severe and sometimes fatal dose dependent hepatitis has been reported with acetaminophen use. Hepatotoxicity has been increased during fasting.

Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.

Gastrointestinal

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin containing rectal suppositories. One case controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

Gastrointestinal side effects have been common and have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose.

Renal

The mechanism of an aspirin induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.

Acetaminophen: Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A case control study of patients with end stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end stage renal disease particularly in patients taking more than two pills per day.

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects have been rare with acetaminophen use and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen related hepatotoxicity.

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity reactions such as anaphylaxis and fixed drug eruptions have rarely been reported in association with acetaminophen use.

The mechanism of aspirin induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.

Rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects from the use of aspirin including Stevens-Johnson syndrome and a lichenoid eruption have been reported rarely.

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP). Erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported.

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.

A case of acetaminophen induced eosinophilic pneumonia has been reported.

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.

Cardiovascular side effects of aspirin have been reported rarely and have included salicylate induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.

Several cases of hypotension have been reported following the administration of acetaminophen.

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has also been reported in a patient on hemodialysis.

Nervous system

Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.

Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.

Endocrine

Endocrine side effects of aspirin use have included hypoglycemia and hyperglycemia.

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.

Oncologic

Oncologic side effects have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found this beneficial effect.

Other side effects

Other side effect have also been reported. In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.

Reye’s syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye’s syndrome has also been reported even more rarely in adults.

Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.

Reye’s syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Excedrin-Migraine overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

1. Upfal J. (2006) The Australian Drug Guide (7th Ed.) Melbourne: Black Inc.[↩][↩]
2. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.[↩]
3. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.[↩]
4. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/[↩]
5. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.[↩][↩]
6. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.[↩]
7. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information[↩]
8. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/[↩]
9. Byer AJ, Traylor TR, Semmer JR “Acetaminophen overdose in the third trimester of pregnancy.” JAMA 247 (1982): 3114-5[↩]
10. Rayburn W, Shukla U, Stetson P, Piehl E “Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women.” Am J Obstet Gynecol 155 (1986): 1353-6[↩][↩]
11. Galinsky RE, Levy G “Absorption and metabolism of acetaminophen shortly before parturition.” Drug Intell Clin Pharm 18 (1984): 977-9[↩]
12. Beaulac-Baillargeon L, Rocheleau S “Paracetamol pharmacokinetics during the first trimester of human pregnancy.” Eur J Clin Pharmacol 46 (1994): 451-4[↩]
13. O’Brien WF, Krammer J, O’Leary TD, Mastrogiannis DS “The effect of acetaminophen on prostacyclin production in pregnant women.” Am J Obstet Gynecol 168 (1993): 1164-9[↩]
14. Briggs GG, Freeman RK, Yaffe SJ.. “Drugs in Pregnancy and Lactation. 5th ed.” Baltimore, MD: Williams & Wilkins;1998[↩]
15. Rudolph AM “Effects of aspirin and acetaminophen in pregnancy and in the newborn.” Arch Intern Med 141 (1981): 358-63[↩][↩]
16. Karlowicz MG, White LE “Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion.” Clin Pediatr (Phila) 32 (1993): 740-3[↩]
17. Schoenfeld A, Bar Y, Merlob P, Ovadia Y “NSAIDs: maternal and fetal considerations.” Am J Reprod Immunol 28 (1992): 141-7[↩]
18. “Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women.” Lancet 343 (1994): 619-29[↩]
19. Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C “Follow-up of children in the italian study of aspirin in pregnancy.” Lancet 343 (1994): 1235[↩][↩]
20. Committee on Drugs, 1992 to 1993 “The transfer of drugs and other chemicals into human milk.” Pediatrics 93 (1994): 137-50[↩]
21. Matheson I, Lunde PK, Notarianni L “Infant rash caused by paracetamol in breast milk.” Pediatrics 76 (1985): 651-2[↩][↩]
22. Erickson SH, Oppenheim GL “Aspirin in breast milk.” J Fam Pract 8 (1979): 189-90[↩]
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24. Berlin CM Jr, Denson HM, Daniel CH, Ward RM “Disposition of dietary caffeine in milk, saliva, and plasma of lactating women.” Pediatrics 73 (1984): 59-63[↩]

What is Orajel

Orajel contains an active ingredient called Benzocaine, which is a local anesthetic (numbing medication) that acts by preventing transmission of impulses along nerve fibers and at nerve endings. Orajel (Benzocaine) works by blocking nerve signals in your body. Orajel (Benzocaine) is used to reduce pain or discomfort from a variety of conditions such as minor skin irritations, sore throats, canker sores, irritation of the mouth and gums, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body.

Health care professionals often use sprays containing benzocaine to numb the mucous membranes inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting instruments down the throat to view internal organs, inserting breathing tubes, and feeding tubes or speculum, however, benzocaine products are not U.S. Food and Drug Administration (FDA)-approved for these uses.

Benzocaine products are available as gels, sprays, ointments, solutions, and lozenges.

Benzocaine products are marketed under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine, and Topex, as well as store brands and generics.

What does Orajel do?

Benzocaine is a local anesthetic commonly used as a topical pain reliever. Orajel (Benzocaine) is an ester of paraaminobenzoic acid, with anesthetic activity. Benzocaine binds to the sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited, thereby blocking the initiation and conduction of nerve impulses along nerve fibers and at nerve endings. The action of benzocaine is completely reversible.

Is Orajel safe for babies?

No. See the U.S. Food and Drug Administration (FDA) warnings on the use of Orajel (Benzocaine) in babies. Furthermore, American Academy of Pediatrics is against the use of the over-the-counter (OTC) topical benzocaine for teething pain in pediatric patients ¹. Due to the adverse side effect such as methemoglobinemia caused by the benzocaine, the Orajel manufacturer’s have decided to discontinue the distribution and sale of Orajel™ teething products containing benzocaine. “The discontinuation is effective immediately and includes Orajel™ Medicated Teething Gel, Orajel™ Medicated Nighttime Teething Gel, Orajel™ Medicated Daytime & Nighttime Teething Twin Pack and Orajel™ Medicated Teething Swabs. We are not discontinuing other Orajel™ products, which represent the majority of our Orajel™ offering” ².

What is Methemoglobinemia?

Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin is produced ⁷. Hemoglobin is the protein in red blood cells (RBCs) that carries and distributes oxygen to the body. Methemoglobin is a form of hemoglobin. With methemoglobinemia, the hemoglobin can carry oxygen, but is not able to release it effectively to body tissues.

Danger signs and symptoms of methemoglobinemia include:

• pale, gray, or blue-colored skin, lips and nail beds
• shortness of breath
• fatigue
• confusion
• headache
• light-headedness
• rapid heart rate

Symptoms can occur within minutes to hours after benzocaine use. They can occur after using the drug for the first time, as well as after several uses.

If your child has any of these symptoms after using benzocaine, stop using the product and seek medical help immediately by calling your local emergency services number for an ambulance.

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

Complications of methemoglobinemia include ⁸:

• Shock
• Seizures
• Death

Methemoglobinemia Exams and Tests ⁸

A baby with this condition will have a bluish skin color (cyanosis). The health care provider will perform blood tests to diagnose the condition. Tests may include:

• Checking the oxygen level in the blood (pulse oximetry)
• Blood test to check levels of gases in the blood (arterial blood gas analysis)

Methemoglobinemia Treatment ⁸

A medicine called methylene blue is used to treat severe methemoglobinemia. Methylene blue may be unsafe in people who have or may be at risk for a blood disease called glucose-6-phosphate dehydrogenase (G6PD). They should not take this medicine. If you or your child has glucose-6-phosphate dehydrogenase (G6PD), always tell your provider before getting treatment.

Ascorbic acid may also be used to reduce the level of methemoglobin.

Alternative treatments include hyperbaric oxygen therapy, red blood cell transfusion and exchange transfusions.

In most cases of mild acquired methemoglobinemia, no treatment is needed. But you should avoid the medicine or chemical that caused the problem. Severe cases may need a blood transfusion.

Outlook (Prognosis)

People with acquired methemoglobinemia often do very well once the drug, food, or chemical that caused the problem is identified and avoided ⁸.

What is the recommendations for treating teething pain in babies?

The American Academy of Pediatrics’ recommendations ⁴ for treating teething pain in 4 to 7 months old babies

Teething usually starts during 4 to 7 months. The two front teeth (central incisors), either upper or lower, usually appear first, followed by the opposite front teeth. The first molars come in next, followed by the canines or eyeteeth.

The timing of teething

There is great variability in the timing of teething. If your child doesn’t show any teeth until later than this age period, don’t worry. The timing may be determined by heredity, and it doesn’t mean that anything is wrong.

How to ease your baby’s discomfort

Teething occasionally may cause mild irritability, crying, a low-grade temperature (but not over 101 ° Fahrenheit or 38.3 ° Celsius), excessive drooling, and a desire to chew on something hard. More often, the gums around the new teeth will swell and be tender. Try gently rubbing or massaging the gums with one of your fingers. Teething rings are helpful, too, but they should be made of firm rubber. (The teethers that you freeze tend to get too hard and can cause more harm than good.) Pain relievers and medications that you rub on the gums are not necessary or useful since they wash out of the baby’s mouth within minutes. Some medication you rub on your child’s gums can even be harmful if too much is used and the child swallows an excessive amount. Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine. Belladonna and benzocaine are marketed to numb your child’s pain, but the FDA (see FDA’s warnings above) has issued warnings against both due to potential side effects.​ If your child seems particularly miserable or has a fever higher than 101 degrees Fahrenheit (38.3 degrees Celsius), it’s probably not because she’s teething, and you should consult your pediatrician.

How should you clean the new teeth?

Simply brush them with a soft child’s toothbrush when you first start seeing her teeth. To prevent cavities, never let your baby fall asleep with a bottle, either at nap time or at night. By avoiding this situation, you’ll keep milk from pooling around the teeth and creating a breeding ground for tooth decay.

Important Information Before Using Orajel

Orajel (Benzocaine) used in the mouth or throat may cause methemoglobinemia, a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. Do not use this medicine if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

• Do not use this medicine on a child younger than 2 years old without medical advice.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount of this medication needed.

Ask a doctor or pharmacist if it is safe for you to use Orajel (Benzocaine) if you have:

• asthma, bronchitis, emphysema, or other breathing disorder;
• heart disease;
• a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or
• if you smoke.

It is not known whether Orajel (Benzocaine) topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether Orajel (Benzocaine) topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Benzocaine Precautions

• Benzocaine topical is considered contraindicated in patients with congenital or idiopathic methemoglobinemia.
• Benzocaine should not be used in infants less than 12 months of age who are receiving treatment with methemoglobin- inducing agents.
• Benzocaine topical is for external use only, and is not intended to be used in or near the eyes.
• Benzocaine crystals may appear as a white precipitate following topical application.
• Do not apply in large quantities or over large, raw, or blistered areas,
• Benzocaine topical is not intended for use on deep or puncture wounds, or serious burns.
• Instruct patients to avoid eating for approximately 1 hour following topical application to oral mucosa.
• Safety and effectiveness of benzocaine sore throat lozenges have not been established in children less than 5 years of age.

How to use Orajel

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of Orajel (Benzocaine), or cover treated skin areas with a bandage or plastic wrap without medical advice.

Your body may absorb more of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Do not use Orajel (Benzocaine) to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

• To treat minor skin conditions, apply a thin layer of Orajel (Benzocaine) to the affected area.
• If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.
• To treat hemorrhoids, apply the medication up to 6 times per day. After cleansing area with soap and water, apply externally to affected area(s) as needed up to 6 times a day. Wash your hands before and after inserting a rectal suppository. Do not take a rectal suppository by mouth. It is for use only in your rectum. Try to empty your bowel and bladder just before using the benzocaine suppository. Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt in your hands. Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first. For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in. Avoid using the bathroom for at least an hour after using the suppository.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using Orajel (Benzocaine). Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Orajel (Benzocaine) is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Orajel (Benzocaine) applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while using Orajel?

Avoid eating within 1 hour after using Orajel (Benzocaine) on your gums or inside your mouth.

Orajel (Benzocaine) is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Orajel side effects

Orajel (Benzocaine) used in the mouth or throat may cause a rare but life-threatening condition called methemoglobinemia. In this condition, the amount of oxygen in your blood stream becomes dangerously low. This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Orajel (Benzocaine) in the mouth or throat.

GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• headache, tired feeling, confusion;
• fast heart rate;
• feeling light-headed or short of breath; and
• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Orajel (Benzocaine) and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied;
• swelling, warmth, or redness; or
• oozing, blistering, or any signs of infection.

Common side effects may include:

• mild stinging, burning, or itching where the medicine is applied;
• skin tenderness or redness; or
• dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch/default.htm) or by phone (1-800-332-1088).

Along with its needed effects, benzocaine topical (the active ingredient contained in Orajel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzocaine topical:
Incidence not known

• Headache
• High fever
• Nausea
• Vomiting
• Worsening of pain, redness, swelling, or irritation in or around the mouth

Side effects apply to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

• Dermatologic side effects have included contact dermatitis and urticaria.

Local

• Local side effects have included burning and stinging.

Other

• Other side effects have included edema.

Cardiovascular

• Cardiovascular side effects have included angioedema.

Hematologic

• Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.

1. Guideline on infant oral health care. American Academy of Pediatric Dentistry. Clinical Affairs Committee–Infant Oral Health Subcommittee. Pediatr Dent. 2012 Sep-Oct; 34(5):e148-52. http://www.aapd.org/publications/[↩]
2. http://www.orajel.com/[↩][↩]
3. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm[↩]
4. Teething: 4 to 7 Months. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx[↩][↩]
5. FDA confirms elevated levels of belladonna in certain homeopathic teething products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm[↩]
6. https://www.ada.org/~/media/ADA/Publications/Files/ADA_PatientSmart_Mouth_Sores.pdf?la=en[↩]
7. Hartman NR, Mao JJ, Zhou H, Boyne MT, Wasserman AM, Taylor K, Racoosin JA, Patel V, Colatsky T. More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems. Regul Toxicol Pharmacol 2014; 70:182-8.[↩]
8. Methemoglobinemia. https://medlineplus.gov/ency/article/000562.htm[↩][↩][↩][↩]

What is Afrin

Afrin nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Afrin is also used to relieve sinus congestion and pressure. Afrin active ingredient is called Oxymetazoline hydrochloride. Afrin (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Afrin (Oxymetazoline) nasal spray carefully and under adult supervision.

Afrin (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Afrin (Oxymetazoline) is available without a prescription.

Afrin Nasal Spray

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Pump Mist

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes so you can breathe more freely

Afrin (Oxymetazoline) is available in the following dosage forms:

• Nasal Pump Mist
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use Afrin Pump Mist:

• Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by
  depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

How does Afrin work?

Afrin (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Afrin (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Afrin – Precautions

• tell your doctor and pharmacist if you are allergic to Afrin (Oxymetazoline), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• Afrin (Oxymetazoline) is contra-indicated with monoamine oxidase inhibitor (MAOI) medicine used for the treatment of depression
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Afrin (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Afrin (Oxymetazoline). This may increase the chance of side effects during treatment.

Geriatric patients

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of Afrin (Oxymetazoline) in the elderly.

Afrin and Pregnancy

Safe use of Afrin (Oxymetazoline) during pregnancy has not been established. Oxymetazoline hydrochloride ophthalmic or nasal solutions should be used during pregnancy only when instructed by a clinician ¹.

• The effects of repeated use of Afrin (Oxymetazoline) nasal spray in a 20-yr-old woman, with uncomplicated pregnancy, resulting in nonreactive nonstress test, late decelerations and fetal heart rate abnormalities, were reported ².
• This investigation ³ studied the effects of Afrin (Oxymetazoline) on the maternal and fetal circulations. Twelve healthy gravid patients in the third trimester (27-39 weeks) underwent flow velocity measurements by the same sonographer using a pulsed Doppler system (ATL Ultramark 4 machine). Maternal and fetal indices were recorded 15 min before dosing, immediately thereafter, and at 15 min intervals during the first 2 hr after the drug was given. No significant changes were found in either the maternal blood pressures or pulse rates. Blood flow velocities did not change significantly from baseline for the uterine arcuate artery, fetal aorta, or umbilical artery circulations. In no case did absolute blood flow velocity decrease significantly or systolic/diastolic ratios elevate to worrisome values. For uncomplicated pregnancies, it was concluded there are no significant acute changes in the maternal and fetal circulations after a single dose of intranasal Afrin (Oxymetazoline) ³.

Afrin and Breastfeeding

Although no information exists on the use of Afrin (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁴. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁴. Topical use on the face is unlikely to present a risk to the nursing infant. However, weigh the potential benefits against the potential risks before taking Afrin (Oxymetazoline) while breastfeeding.

• Maternal Drug Levels. Relevant published information was not found.
• Infant Drug Levels. Relevant published information was not found.
• Effects in Breastfed Infants: Relevant published information was not found.
• Effects on Lactation and Breastmilk: Relevant published information was not found.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Afrin (Oxymetazoline), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Afrin (Oxymetazoline) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dryness in nose or
• High blood pressure or
• Tachycardia (fast heart rate) or
• Trouble urinating from an enlarged prostate—May make these conditions worse.

How should Afrin be used?

Afrin (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Afrin (Oxymetazoline) nasal spray is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Afrin (Oxymetazoline) nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use Afrin (Oxymetazoline) nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use Afrin (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Afrin (Oxymetazoline) and call your doctor.

Afrin (Oxymetazoline) nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the Afrin (Oxymetazoline) nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the Afrin (Oxymetazoline) nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

To use Afrin pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

Afrin Dosing

The dose of Afrin (Oxymetazoline) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Afrin (Oxymetazoline) that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Afrin (Oxymetazoline) nasal dosage form (pump mist or nasal spray):

• For nasal congestion or stuffiness:
  • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  • Children up to 6 years of age—Use and dose must be determined by your doctor.

What if I forget to take it?

If you miss a dose of Afrin (Oxymetazoline), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Afrin Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Nasal Spray Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Nasal Spray Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Nasal Spray Directions of Use

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Afrin Nasal Spray Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin Pump Mist

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Pump Mist Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Pump Mist Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Pump Mist Directions of Use

To use pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Afrin Pump Mist Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin side effects

Afrin (Oxymetazoline) may cause side effects.

Common side effects

• Transient burning, stinging, increased nasal discharge
• Dryness inside the nose
• Sneezing
• Difficulty falling asleep or staying asleep
• Rebound congestion with prolonged use (4-5 days)
• Rebound congestion is associated with overuse and may take several weeks to reverse

Tell your doctor if any of these symptoms are severe or do not go away.

Uncommon side effects

• Hypertension
• Nausea
• Nervousness
• Dizziness
• Drowsiness
• Insomnia
• Headache
• CNS (central nervous system) effects are more common in children

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast heartbeat
• slow heartbeat

Oxymetazoline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Human Toxicity Reports

Intranasal use of oxymetazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, or reflex bradycardia ¹.

A total of 307 patients with acute rhinitis entered a study to compare the difference between oxymetazoline with preservative and oxymetazoline without preservative. The treatment with oxymetazoline with preservative and oxymetazoline without preservative and xylometazoline with preservative was evaluated. This randomized, double-blind, multi-centered, tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters “feeling of dryness in nasal mucosa” and “burning sensation”, a 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride ⁵.

A case report of an abrupt withdrawal in a healthy man of oxymetazoline nasal spray precipitated a prolonged panic disorder that required hospitalization with extensive evaluations ⁶.

Excessive dosage and/or prolonged or too frequent intranasal use of oxymetazoline may irritate nasal mucosa and especially in children, cause adverse systemic effects. Excessive dosage or inadvertent ingestion in children may cause profound CNS (central nervous system) depression, possibly necessitating intensive supportive care ¹. CNS depression, shock-like hypotension, and coma have occurred following overdosage of naphazoline and tetrahydrozoline; the possibility that this may occur with oxymetazoline should be considered ¹.

In this case report, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation ⁷.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ⁸. Cardiac ultrasound showed a calcified lesion, presumably a fibroma arising from the interventricular septum. Fascicular tachycardia related to the lesion and provoked by the use of a sympathomimetic agent is postulated ⁸.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ⁹. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ⁹. Although she was using the medication at recommended daily dosages (2–3 sprays twice daily), she was using it consistently. Two weeks before presentation she had noticed a pattern of headache starting 20 minutes after use of the nasal spray. The event had occurred immediately after its use. Thunderclap headache is a hyperacute, severe headache that is so named because of its sudden onset. It often heralds a serious intracranial vascular event such as subarachnoid hemorrhage, cerebral venous sinus thrombosis or pituitary apoplexy. However, it may also occur spontaneously or in the setting of cerebral vasoconstriction. Narcotic analgesics reduced the pain, but the nausea and vomiting responded to ondansetron only. The patient had no improvement in her headache with nimodipine, a calcium-channel antagonist that causes dilatation of arterial smooth muscle. Two weeks after discharge the headache had nearly resolved. A repeat angiogram at 6 weeks showed complete resolution of most areas of arterial narrowing ⁹. This case report illustrates that oxymetazoline can cause reversible segmental cerebral vasoconstriction, resulting in thunderclap headache.

A case report of 43-year-old woman who was evaluated for sequential bilateral vision loss following the use of oxymetazoline nasal spray. Thorough investigation of possible causes causing the bilateral anterior ischemic optic neuropathy was negative. The patient had several predisposing risk factors for ischemic optic neuropathy, including diabetes mellitus, hypertension, and crowded optic nerve heads. Before each acute optic neuropathy, the patient used two to three puffs of oxymetazoline nasal spray ¹⁰.

A case report of a young, otherwise healthy man presented with an acute retinal artery obstruction following excessive use of oxymethazolone hydrochloride 0.5% nasal spray ¹¹. Platelet coagulation studies indicated a platelet aggregation hypersensitivity to adenosine diphosphate and epinephrine. A predisposition for sympathomimetic drug-induced platelet fibrin embolus formation appears to be the cause of the retinal artery obstruction in this case ¹¹.

A case is presented in which a 73-yr-old man who was using Afrin (oxymetazoline hydrochloride) nasal spray several times daily, for the treatment of nasal congestion, developed bradycardia, hypotension and dizziness associated with oxymetazoline hydrochloride ¹².

1. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824[↩][↩][↩][↩]
2. Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985[↩]
3. Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990[↩][↩]
4. Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604[↩][↩]
5. Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532[↩]
6. Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333[↩]
7. Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470[↩]
8. Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069[↩][↩]
9. Loewen AHS, Hudon ME, Hill MD. Thunderclap headache and reversible segmental cerebral vasoconstriction associated with use of oxymetazoline nasal spray. CMAJ : Canadian Medical Association Journal. 2004;171(6):593-594. doi:10.1503/cmaj.1040631. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC516194/[↩][↩][↩]
10. Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016[↩]
11. Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795[↩][↩]
12. Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983[↩]

What is Zicam

Zicam nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Zicam is also used to relieve sinus congestion and pressure. Zicam active ingredient is called Oxymetazoline hydrochloride. Zicam (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Zicam (Oxymetazoline) nasal spray carefully and under adult supervision.

Zicam (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Zicam (Oxymetazoline) is available without a prescription.

Zicam Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes

Zicam (Oxymetazoline) is available in the following dosage forms:

• Nasal Solution
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

How much zinc is in Zicam?

Zicam (Oxymetazoline) nasal spray does not contain any zinc.

Active ingredients: Oxymetazoline hydrochloride 0.05%

Inactive ingredients: aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

How does Zicam work?

Zicam (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Zicam (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Zicam – Precautions

• tell your doctor and pharmacist if you are allergic to Zicam (Oxymetazoline), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• Zicam (Oxymetazoline) is contra-indicated with monoamine oxidase inhibitor (MAOI) medicine used for the treatment of depression
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Zicam (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Zicam (Oxymetazoline). This may increase the chance of side effects during treatment.

Geriatric patients

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of Zicam (Oxymetazoline) in the elderly.

Zicam and Pregnancy

Safe use of Zicam (Oxymetazoline) during pregnancy has not been established. Oxymetazoline hydrochloride ophthalmic or nasal solutions should be used during pregnancy only when instructed by a clinician ¹.

• The effects of repeated use of Zicam (Oxymetazoline) nasal spray in a 20-yr-old woman, with uncomplicated pregnancy, resulting in nonreactive nonstress test, late decelerations and fetal heart rate abnormalities, were reported ².
• This investigation ³ studied the effects of Zicam (Oxymetazoline) on the maternal and fetal circulations. Twelve healthy gravid patients in the third trimester (27-39 weeks) underwent flow velocity measurements by the same sonographer using a pulsed Doppler system (ATL Ultramark 4 machine). Maternal and fetal indices were recorded 15 min before dosing, immediately thereafter, and at 15 min intervals during the first 2 hr after the drug was given. No significant changes were found in either the maternal blood pressures or pulse rates. Blood flow velocities did not change significantly from baseline for the uterine arcuate artery, fetal aorta, or umbilical artery circulations. In no case did absolute blood flow velocity decrease significantly or systolic/diastolic ratios elevate to worrisome values. For uncomplicated pregnancies, it was concluded there are no significant acute changes in the maternal and fetal circulations after a single dose of intranasal Zicam (Oxymetazoline) ³.

Zicam and Breastfeeding

Although no information exists on the use of Zicam (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁴. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁴. Topical use on the face is unlikely to present a risk to the nursing infant. However, weigh the potential benefits against the potential risks before taking Zicam (Oxymetazoline) while breastfeeding.

• Maternal Drug Levels. Relevant published information was not found.
• Infant Drug Levels. Relevant published information was not found.
• Effects in Breastfed Infants: Relevant published information was not found.
• Effects on Lactation and Breastmilk: Relevant published information was not found.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Zicam (Oxymetazoline), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Zicam (Oxymetazoline) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dryness in nose or
• High blood pressure or
• Tachycardia (fast heart rate) or
• Trouble urinating from an enlarged prostate—May make these conditions worse.

How should Zicam be used?

Zicam (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Zicam (Oxymetazoline) nasal spray is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Zicam (Oxymetazoline) nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use Zicam (Oxymetazoline) nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use Zicam (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Zicam (Oxymetazoline) and call your doctor.

Zicam (Oxymetazoline) nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the Zicam (Oxymetazoline) nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the Zicam (Oxymetazoline) nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

How to use the Zicam nose spray

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. If needed, blow the nose gently again and repeat the spray process until the total dose is used.
• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

To use the Zicam nose drops

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

Zicam Dosing

The dose of Zicam (Oxymetazoline) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Zicam (Oxymetazoline) that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Zicam (Oxymetazoline) nasal dosage form (nose drops or spray):

• For nasal congestion or stuffiness:
  • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  • Children up to 6 years of age—Use and dose must be determined by your doctor.

What if I forget to take it?

If you miss a dose of Zicam (Oxymetazoline), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Zicam Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

Other information

• store between 15-29°C (59-84°F)
• retain carton for future reference on full labeling

Zicam Nasal Spray Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes

Zicam Nasal Spray Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Zicam Nasal Spray Directions of Use

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Zicam Nasal Spray Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Zicam side effects

Zicam (Oxymetazoline) may cause side effects.

Common side effects

• Transient burning, stinging, increased nasal discharge
• Dryness inside the nose
• Sneezing
• Difficulty falling asleep or staying asleep
• Rebound congestion with prolonged use (4-5 days)
• Rebound congestion is associated with overuse and may take several weeks to reverse

Tell your doctor if any of these symptoms are severe or do not go away.

Uncommon side effects

• Hypertension
• Nausea
• Nervousness
• Dizziness
• Drowsiness
• Insomnia
• Headache
• CNS (central nervous system) effects are more common in children

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast heartbeat
• slow heartbeat

Oxymetazoline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Human Toxicity Reports

Intranasal use of oxymetazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, or reflex bradycardia ¹.

A total of 307 patients with acute rhinitis entered a study to compare the difference between oxymetazoline with preservative and oxymetazoline without preservative. The treatment with oxymetazoline with preservative and oxymetazoline without preservative and xylometazoline with preservative was evaluated. This randomized, double-blind, multi-centered, tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters “feeling of dryness in nasal mucosa” and “burning sensation”, a 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride ⁵.

A case report of an abrupt withdrawal in a healthy man of oxymetazoline nasal spray precipitated a prolonged panic disorder that required hospitalization with extensive evaluations ⁶.

Excessive dosage and/or prolonged or too frequent intranasal use of oxymetazoline may irritate nasal mucosa and especially in children, cause adverse systemic effects. Excessive dosage or inadvertent ingestion in children may cause profound CNS (central nervous system) depression, possibly necessitating intensive supportive care ¹. CNS depression, shock-like hypotension, and coma have occurred following overdosage of naphazoline and tetrahydrozoline; the possibility that this may occur with oxymetazoline should be considered ¹.

In this case report, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation ⁷.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ⁸. Cardiac ultrasound showed a calcified lesion, presumably a fibroma arising from the interventricular septum. Fascicular tachycardia related to the lesion and provoked by the use of a sympathomimetic agent is postulated ⁸.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ⁹. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ⁹. Although she was using the medication at recommended daily dosages (2–3 sprays twice daily), she was using it consistently. Two weeks before presentation she had noticed a pattern of headache starting 20 minutes after use of the nasal spray. The event had occurred immediately after its use. Thunderclap headache is a hyperacute, severe headache that is so named because of its sudden onset. It often heralds a serious intracranial vascular event such as subarachnoid hemorrhage, cerebral venous sinus thrombosis or pituitary apoplexy. However, it may also occur spontaneously or in the setting of cerebral vasoconstriction. Narcotic analgesics reduced the pain, but the nausea and vomiting responded to ondansetron only. The patient had no improvement in her headache with nimodipine, a calcium-channel antagonist that causes dilatation of arterial smooth muscle. Two weeks after discharge the headache had nearly resolved. A repeat angiogram at 6 weeks showed complete resolution of most areas of arterial narrowing ⁹. This case report illustrates that oxymetazoline can cause reversible segmental cerebral vasoconstriction, resulting in thunderclap headache.

A case report of 43-year-old woman who was evaluated for sequential bilateral vision loss following the use of oxymetazoline nasal spray. Thorough investigation of possible causes causing the bilateral anterior ischemic optic neuropathy was negative. The patient had several predisposing risk factors for ischemic optic neuropathy, including diabetes mellitus, hypertension, and crowded optic nerve heads. Before each acute optic neuropathy, the patient used two to three puffs of oxymetazoline nasal spray ¹⁰.

A case report of a young, otherwise healthy man presented with an acute retinal artery obstruction following excessive use of oxymethazolone hydrochloride 0.5% nasal spray ¹¹. Platelet coagulation studies indicated a platelet aggregation hypersensitivity to adenosine diphosphate and epinephrine. A predisposition for sympathomimetic drug-induced platelet fibrin embolus formation appears to be the cause of the retinal artery obstruction in this case ¹¹.

A case is presented in which a 73-yr-old man who was using Afrin (oxymetazoline hydrochloride) nasal spray several times daily, for the treatment of nasal congestion, developed bradycardia, hypotension and dizziness associated with oxymetazoline hydrochloride ¹².

1. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824[↩][↩][↩][↩]
2. Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985[↩]
3. Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990[↩][↩]
4. Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604[↩][↩]
5. Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532[↩]
6. Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333[↩]
7. Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470[↩]
8. Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069[↩][↩]
9. Loewen AHS, Hudon ME, Hill MD. Thunderclap headache and reversible segmental cerebral vasoconstriction associated with use of oxymetazoline nasal spray. CMAJ : Canadian Medical Association Journal. 2004;171(6):593-594. doi:10.1503/cmaj.1040631. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC516194/[↩][↩][↩]
10. Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016[↩]
11. Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795[↩][↩]
12. Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983[↩]

What is Dulcolax

Dulcolax is a stimulant laxative used to relieve constipation and also to prepare the bowel for diagnostic or surgical procedures requiring the bowel to be empty. The active ingredient in Dulcolax is Bisacodyl, which is a diphenylmethane laxative that acts by directly stimulating the nerve endings in the mucosa of the colon, increasing the movement of the intestines. Dulcolax (Bisacodyl) can help you empty your bowels if you have constipation (difficulty pooing).

Dulcolax (Bisacodyl) is used in hospitals to help you empty your bowels before surgery or some examinations or treatments. Your hospital will explain how to use it.

Dulcolax (Bisacodyl) comes as a tablet and a suppository (a medicine that you push gently into your back passage).

The Dulcolax (Bisacodyl) tablets and suppositories are available on prescription and to buy from pharmacies.

Key facts

• Dulcolax (Bisacodyl) tablets take 6 to 12 hours to work.
• Dulcolax (Bisacodyl) suppositories take 10 to 45 minutes to work, so it’s best to stay close to a toilet.
• The most common side effects are feeling sick (nausea), diarrhea, stomach pain or cramps.
• Only give Dulcolax (Bisacodyl) to children if their doctor recommends it.
• Do not take Dulcolax (Bisacodyl) tablets or use Dulcolax (Bisacodyl) suppositories every day for more than 5 days.
• Bisacodyl is also called by the brand name Alophen Pills, Bisac-Evac, Carter’s Little Pills, Correctol, Dulcolax, Feen-A-Mint, Fleet Bisacodyl, Bisacodyl Uniserts, Fleet Bisacodyl Enema, Dulcolax Bowel Prep Kit and Dulcolax.

How does Dulcolax work

Dulcolax (Bisacodyl) is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Dulcolax (Bisacodyl) is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures.

Dulcolax (Bisacodyl) has been used to facilitate flushing of colostomies and may reduce or eliminate the need for irrigations.

Dulcolax (Bisacodyl) is used:

• to treat constipation that occurs following prolonged bed rest or hospitalization.
• to treat chronic constipation associated with opiate therapy.
• to treat constipation occurring secondary to idiopathic slowing of transit time, to constipating drugs, or to irritable bowel or spastic colon syndrome.
• to treat constipation in patients with neurologic constipation.

How should Dulcolax be used?

Dulcolax (Bisacodyl) comes as a tablet to take by mouth. Swallow the tablets whole with a glass of water; do not split, chew, or crush them. Do not take Dulcolax (Bisacodyl) within 1 hour after drinking or eating dairy products. Dulcolax (Bisacodyl) is usually taken the evening before a bowel movement is desired. Do not take Dulcolax (Bisacodyl) more than once a day or for more than 1 week without talking to your doctor. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Dulcolax (Bisacodyl) exactly as directed. Frequent or continued use of Dulcolax (Bisacodyl) may make you dependent on laxatives and cause your bowels to lose their normal activity.

What special dietary instructions should I follow?

A regular diet and exercise program is important for regular bowel function. Eat a high-fiber diet and drink plenty of liquids (eight glasses) each day as recommended by your doctor.

How long does it take for Dulcolax to work?

Dulcolax (Bisacodyl) tablet taken by mouth normally causes a bowel movement within 6 to 12 hours. If you do not have a regular bowel movement after taking Dulcolax (Bisacodyl), do not take any more medication and talk to your doctor.

Dulcolax (Bisacodyl) suppositories take 10 to 45 minutes to work, so it’s best to stay close to a toilet.

How long should I take Dulcolax for?

Do not take Dulcolax (Bisacodyl) every day for more than 5 days. If you are still constipated after that, talk to your doctor.

Is it safe to take Dulcolax for a long time?

Ideally, you should only use Dulcolax (Bisacodyl) occasionally and for a few days at a time.

Using laxatives like Dulcolax (Bisacodyl) for longer can lead to a fluid and salt imbalance in your body and you may become dehydrated.

If you need to use laxatives every day for a longer time, talk to your doctor.

With long term use or overdosage of stimulant laxatives, electrolyte disturbances including hypokalemia, hypocalcemia, metabolic acidosis or alkalosis, abdominal pain, diarrhea, malabsorption, weight loss, and protein-losing enteropathy may occur ¹. Electrolyte disturbances may produce vomiting and muscle weakness; rarely osteomalacia, secondary aldosteronism, and tetany may occur. Pathologic changes in including structural damage to the myenteric plexus, severe and permanent interference with colonic motility, and hypertrophy of the muscularis mucosae may occur with chronic use ¹.

Can I take different laxatives together?

For most people, 1 laxative will be enough to make your constipation better.

Occasionally, you may need to take 2 different types of laxatives at the same time to get your bowels moving again. Only take 2 laxatives together if your doctor or pharmacist tell you to as this increases the risk of side effects.

Are other laxatives any better?

There are other types of laxative. They work in a different way from Dulcolax (Bisacodyl), but are equally good at treating constipation.

• Bulk-forming laxatives, for example Fybogel and methylcellulose. These increase the “bulk” or weight of poo, which in turn stimulates bowel movement. They take 2 or 3 days to work.
• Osmotic laxatives, for example lactulose. These draw water from the rest of the body into your bowel to soften your poo and make it easier to pass. They take at least 2 days to work.
• Stimulant laxatives, for example senna. These stimulate the muscles that line your gut, helping them to move poo along your gut to your back passage. Senna takes about 8 hours to work.

Can I use Dulcolax after surgery?

It’s quite common to have constipation after surgery. Using a laxative may help.

If you have constipation after an operation, it’s better to use lactulose because it is gentler than Dulcolax (Bisacodyl). You can get it on prescription or buy it from pharmacies.

Can lifestyle changes help constipation?

It’s often possible to improve constipation without having to use laxatives. Before trying Dulcolax (Bisacodyl) – or to stop constipation coming back – it may help to:

• eat more fiber – aim for about 30-35 g of fiber a day. High-fiber foods include fruit, vegetables and cereals. If you’re not used to a high-fiber diet, increase the amount of fiber you eat gradually.
• add bulking agents, such as wheat bran, to your diet. These will help make your poo softer and easier to pass (although bran and fiber can sometimes make bloating worse).
• drink plenty of water – to keep poo soft.
• exercise regularly – keeping your body active will help to keep your gut moving.
• go to the toilet when you need to, rather than holding it in.

Who can and can’t take Dulcolax

Dulcolax (Bisacodyl) can be used by adults.

Dulcolax (Bisacodyl) can also be used by children, if their doctor recommends it. Doctors normally only recommend it for children aged 4 years and older. Occasionally, they recommend it for children aged 2 years and older.

Dulcolax (Bisacodyl) enteric-coated tablets are not recommenced for children up to 6 years of age since patients in this age group may have difficulty swallowing the tablet without chewing it ². Gastric irritation may develop if the enteric coating is destroyed by chewing ².

Furthermore, laxatives should not be given to young children unless prescribed by a physician. Since children are not usually able to describe their symptoms precisely, proper diagnosis should precede the use of laxatives ². This will avoid the complication of an existing condition (e.g., appendicitis) or the appearance of more severe side effects ².

Dulcolax (Bisacodyl) isn’t suitable for some people. To make sure it’s safe for you, tell your doctor or pharmacist if you have:

• ever had an allergic reaction to Dulcolax (Bisacodyl) or any other medicines in the past
• signs of dehydration
• severe stomach pain and you are feeling sick or being sick (nausea or vomiting)
• a serious problem in your tummy (abdomen), such as appendicitis, a blockage in your bowel (intestinal obstruction), ulcerative colitis or Crohn’s disease, or a problem with the muscles in your bowel not being able to move food and liquid along

For Dulcolax (Bisacodyl) tablets, also tell your doctor or pharmacist if you:

• can’t digest some sugars – the tablets contain a small amount of lactose and sucrose

For Dulcolax (Bisacodyl) suppositories, also tell your doctor or pharmacist if you have:

• ever had an allergic reaction to suppositories
• tears or open sores (anal fissures) or cracked skin around your back passage (anus)

Before taking Dulcolax – Precautions

• tell your doctor and pharmacist if you are allergic to Dulcolax (Bisacodyl), any other medications, or any of the ingredients in these products. Check the label or ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, wait at least 1 hour before taking Dulcolax (Bisacodyl).
• tell your doctor if you have stomach pain, nausea, vomiting, or a sudden change in bowel movements lasting more than 2 weeks.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Dulcolax (Bisacodyl), call your doctor.
• talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take Dulcolax (Bisacodyl) because it is not as safe or effective as other medications that can be used to treat the same condition.
• Stimulant laxatives are habit forming and long term use of these drugs may result in laxative dependence and loss of normal bowel function ¹.

Cautions with other medicines

Some medicines – and some foods – interfere with the way Dulcolax (Bisacodyl) works.

For safety, tell your doctor or pharmacist if you are taking any other medicines, including herbal remedies, vitamins or supplements.

They include:

• water tablets (diuretics), steroids (like prednisolone) or digoxin (a heart medicine) – these can upset the balance of salts and minerals in your body if you have too much Dulcolax (Bisacodyl) by accident. If you are taking digoxin, this imbalance makes it more likely you will have the serious side effects of digoxin. It’s important not to take too much Dulcolax (Bisacodyl) if you are taking any of these medicines.
• indigestion remedies (antacids) and dairy products like milk, cheese and yogurt – these interact with Dulcolax (Bisacodyl) tablets and stop them working properly. They can also make the Dulcolax (Bisacodyl) irritate your stomach and give you indigestion. Do not take Dulcolax (Bisacodyl) at the same time – leave a gap of 1 hour before or after taking Dulcolax (Bisacodyl) if you are having indigestion remedies or dairy products. The small amount of milk in coffee and tea is unlikely to affect it, but it’s best to take Dulcolax (Bisacodyl) tablets with a glass of water.

Mixing Dulcolax (Bisacodyl) with herbal remedies or supplements

There is not enough research to know if complementary medicines and herbal remedies are safe to take with Dulcolax (Bisacodyl).

Dulcolax in Pregnancy and Breastfeeding

Tell your pharmacist or doctor if you are trying to get pregnant, already pregnant, or breastfeeding.

FDA Pregnancy Risk Category B: NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility ³.

Dulcolax (Bisacodyl) tablets or suppositories are not generally recommended if you are pregnant, especially in the first 3 months and while you are breastfeeding. Talk to your doctor about the benefits and risks of taking Dulcolax (Bisacodyl).

If you are pregnant or breastfeeding, it’s always better to try to treat constipation without taking a medicine. Your doctor or midwife will first advise you to eat more fibre and drink plenty of fluids. It may also help to do gentle exercise.

If diet and lifestyle changes do not work, your doctor or midwife may recommend another laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

I just found out I am pregnant. Should I stop taking Dulcolax?

Always talk with your healthcare provider before making any changes in your medications. It is important to consider the benefits of treating constipation symptoms during pregnancy.

Constipation may cause pain and other health problems in pregnancy such as cramps, hemorrhoids, and breakdown of the anal tissue. Treating constipation will help reduce the risk of these problems. Dietary changes such as increasing fluids, eating high fiber foods such as whole grains and fresh fruits and vegetables can help prevent constipation. Regular exercise can also help. Although occasional constipation is common in pregnancy, talk with your healthcare provider if constipation becomes an ongoing problem. Your healthcare provider may also want to confirm the diagnosis of constipation and see how dietary and exercise changes can help before discussing medical treatment.

Can the use of laxatives during pregnancy cause birth defects?

Few studies have been done to look at the possible risks from using laxatives during pregnancy. However, the available studies show that when used in recommended doses, laxatives are not expected to increase the risk of birth defects or pregnancy problems.

Are there other concerns when using laxatives?

Yes. Laxatives may reduce the amount of nutrition and medicines that get into the blood since laxatives can make food go through the intestines faster than usual. Nutritional problems are only seen when these agents are used more than recommended.

When more than the recommended amounts of laxatives are used, some can also lower the levels of salts, such as magnesium, in a person’s blood. There is one reported case of low magnesium levels in a newborn that was linked to the mother using too much docusate sodium. The baby’s main symptom was jitteriness, which went away by the second day of life.

Castor oil has been used at the end of pregnancy to bring on labor. It can cause severe diarrhea and cramping of the bowel and uterus. However, if the lower part of the uterus (cervix) is not ready, these contractions will not bring on labor. If you are at the end of your pregnancy, your health care provider can discuss other ways to begin labor.

Dulcolax and Breastfeeding

Dulcolax (Bisacodyl) is not absorbed from the gastrointestinal tract, and its active metabolite, which is absorbed, is not detectable in breastmilk ⁴. Dulcolax (Bisacodyl) can be taken during breastfeeding and no special precautions are required ⁴. Sixteen postpartum women who were not breastfeeding, but were producing at least 200 mL of milk daily by breast pump were given either oral enteric-coated bisacodyl tablets (Dulcolax) 10 mg daily or oral liquid sodium picosulfate (Laxoberal) 10 mg daily for 7 days ⁵. Both drugs are prodrugs metabolized to the active drug, bis-(p-hydroxyphenyl)-2-pyridyl-2-methane. All breastmilk was collected daily from the day before drug administration to 2 days after the last dose. Free and conjugated bis-(p-hydroxyphenyl)-2-pyridyl-2-methane were undetectable (<1 mcg/L) in all milk samples ⁵.

How and when to take Dulcolax

Before using rectal Dulcolax

• tell your doctor and pharmacist if you are allergic to Dulcolax (Bisacodyl), any other medications, or any of the ingredients in these products. Check the label or ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have stomach pain, nausea, vomiting, a sudden change in bowel movements lasting more than 2 weeks, anal fissures, or hemorrhoids.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using rectal Dulcolax (Bisacodyl), call your doctor.
• talk to your doctor about the risks and benefits of using this medication if you are 65 years of age or older. Older adults should not usually use rectal Dulcolax (Bisacodyl) because it is not as safe or effective as other medications that can be used to treat the same condition.

How to take Dulcolax

Dulcolax (Bisacodyl) Tablets

• Take the medicine once a day just before bedtime.
• You can take it with or without food. Swallow the tablet whole with water.
• Do not have milk, indigestion remedies (antacids) or medicines to reduce stomach acid (for example, proton pump inhibitors) at the same time as Dulcolax (Bisacodyl). This is because they will stop the medicine working properly. Leave a gap of 1 hour between taking any of these and taking your Dulcolax (Bisacodyl) tablets.

Dulcolax (Bisacodyl) Suppositories

• Take the wrapping off and push a suppository gently into your back passage (anus).
• Suppositories work quickly (usually between 10 and 45 minutes), so use it when you know you will be near a toilet.
• Read the instructions in the leaflet inside the package. They will explain how to use the suppository.

Rectal Dulcolax (Bisacodyl) comes as a suppository and enema to use rectally. It is usually used at the time that a bowel movement is desired. The suppositories usually cause a bowel movement within 15 to 60 minutes and the enema within 5 to 20 minutes. Do not use Dulcolax (Bisacodyl) more than once a day or for more than 1 week without talking to your doctor. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use rectal Dulcolax (Bisacodyl) exactly as directed. Frequent or continued use of Dulcolax (Bisacodyl) may make you dependent on laxatives and cause your bowels to lose their normal activity. If you do not have a regular bowel movement after using Dulcolax (Bisacodyl), do not use this medication again and talk to your doctor.

If using a Dulcolax (Bisacodyl) suppository, follow these steps:

1. If the suppository is soft, hold it under cool water or place it in the refrigerator for a few minutes to harden it before removing the wrapper.
2. Remove the wrapper.
3. If you were told to use half of the suppository, cut it lengthwise with a clean, sharp knife or blade.
4. Lie down on your left side and raise your right knee to your chest.
5. Using your finger, insert the suppository, pointed end first, into your rectum until it passes the muscular sphincter of the rectum, about 1 inch (2.5 centimeters) in adults. If not inserted past this sphincter, the suppository may pop out.
6. Hold it in place for as long as possible.
7. Wash your hands thoroughly.

If using a Dulcolax (Bisacodyl) enema, follow these steps:

1. Shake the enema bottle well.
2. Remove the protective shield from the tip.
3. Lie down on your left side and raise your right knee to your chest or kneel and lean forward so that your head and chest are resting comfortably.
4. Gently insert the enema bottle into the rectum with the tip pointing toward the navel.
5. Squeeze the bottle gently until the bottle is nearly empty.
6. Remove the enema bottle from the rectum. Hold the enema contents in place as long as possible, for up to 10 minutes.
7. Wash your hands thoroughly.

How much Dulcolax to take

Dulcolax (Bisacodyl) Tablets

The usual dose in:

• adults and children aged 12 years and over is 5—15 mg/day (1 to 3 tablets) once a day before bedtime
• children aged 6 to 11 years old is 5 mg (1 tablet) a day before bedtime, if their doctor recommends it

If you are an adult or child aged 10 and over and you have not taken Dulcolax (Bisacodyl) before, start with 1 tablet. If that doesn’t work well enough for you, you can take 2 tablets.

Dulcolax (Bisacodyl) Suppositories

The usual dose for:

• adults and children aged 12 years and over is 1 suppository (10mg) a day
• children 6 to 12 years old is 1 suppository (5mg) a day, if their doctor recommends it

What if I forget to take it?

If you forget a dose of Dulcolax (Bisacodyl), don’t worry. Just take the next dose at the usual time.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

What if I take too much?

Taking an extra dose of Dulcolax (Bisacodyl) by accident is unlikely to harm you. You may get diarrhea and stomach pain, but this should get better within a day or two.

If you’re worried, talk to your doctor or pharmacist for advice.

Is there any food and drink I need to avoid?

Do not take Dulcolax (Bisacodyl) at the same time as dairy products like milk, cheese or yogurt. Leave a gap of 1 hour between taking any of these and taking your Dulcolax (Bisacodyl) tablets. The small amount of milk in coffee and tea should not affect the Dulcolax (Bisacodyl) tablet.

It’s a good idea to stop eating pastries, cakes, puddings and cheese for a while as these can make constipation worse.

Can I drink alcohol with Dulcolax?

Yes, you can drink alcohol with Dulcolax (Bisacodyl).

Dulcolax dosage

Dulcolax Laxative Tablets

Active ingredient (in each suppository): Bisacodyl USP 5 mg
Purpose: Stimulant laxative

Dulcolax Laxative Tablets Warnings

• Dulcolax Laxative Tablets can be can be taken with water and must be swallowed whole.
• The tablets must NOT be chewed or crushed. Dulcolax Laxative Tablets are coated to prevent the active ingredient from being released until it reaches the part of the intestines where it is needed to work.
• Do not use if you cannot swallow without chewing

Ask a doctor before use if you have:

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps.

Stop use and ask a doctor if:

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Do not use this product if the individual seal is broken

Dulcolax Laxative Tablets Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours
• Dulcolax Laxative Tablets can generally be taken at any time except within one hour of consuming dairy products or antacids. Dulcolax Laxative tablets have a special ‘enteric coating’, which protects the tablet from the stomach’s acidic environment and ensures it is released in the small intestine where it is needed most.

When using Dulcolax Laxative Tablets:

• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps

Dulcolax Laxative Tablets Dosage

• Take Dulcolax Laxative Tablets with a glass of water
• Adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose
  • If this is the first time you are taking this product, it’s recommend taking 1 to 2 tablets in a single daily dose. It is suggested to take the tablets within 30 to 60 minutes before your normal bedtime to produce a bowel movement the next morning. With experience, you may increase your daily dosage to 2 or 3 tablets, if needed.
• Children 6 to under 12 years of age: 1 tablet in a single daily dose
• Children under 6 years of age: Ask a doctor

What time of day should I take Dulcolax Laxative Tablets?

It is recommended that you take Dulcolax Laxative Tablets when you can allow 6 to 12 hours for the product to work. You may find that it is most convenient to take the product about 30 to 60 minutes before your normal bedtime in order to produce a bowel movement in the morning.

Can I take Dulcolax Laxative Tablets with milk or dairy products?

No. This product should not be taken with milk or dairy products. Do not take Dulcolax laxative tablets within one hour of taking indigestion remedies (antacids) or dairy products such as milk or yogurt as these could cause the tablet’s comfort (enteric) coating to dissolve before it reaches the colon which may result in vomiting or cramping.

Is it safe to use Dulcolax Laxative Tablets on a daily basis?

You may take up to 3 Dulcolax Laxative Tablets a day for up to 7 days. If you need to use a laxative for more than 7 days, consult a health professional.

Dulcolax Laxative Suppositories

Active ingredient (in each suppository): Bisacodyl USP 10 mg
Purpose: Stimulant laxative

Dulcolax Laxative Suppositories Warnings

• For rectal use only. They are NOT intended for oral or vaginal use.
  

Ask a doctor before use if you have:

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps.

Stop use and ask a doctor if:

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Do not use this product if the individual seal is broken

Dulcolax Laxative Suppositories Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 15 minutes to 1 hour

Dulcolax Laxative Suppositories Dosage

• Adults and children 12 years of age and over: 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
• Children 6 to under 12 years of age: 1/2 suppository in a single daily dose
• Children under 6 years of age: Ask a doctor

What time of day should I take Dulcolax Laxative Suppositories?

You may take a Dulcolax Laxative Suppository anytime. It generally produces a bowel movement in 15 to 60 minutes.

How often can I take Dulcolax Laxative Suppositories?

Is it safe for daily use?

You may take 1 Dulcolax Laxative Suppository a day for up to 7 days. If you need to use a laxative for more than 7 days, consult a doctor.

How do I use Dulcolax Laxative Suppositories?

What does retain mean?

Remove the suppository from the plastic wrapping and insert the suppository, pointed end first, into the rectum. For best results, you should lie down for 15 to 20 minutes and try to retain the suppository for as long as you can. To retain the suppository means to keep the suppository in the rectum.

Do I need to remove the suppository after it has been inserted?

The Dulcolax Laxative Suppository does not need to be removed after it has been inserted; it works in the rectum within 15-60 minutes.

Dulcolax side effects

Like all medicines, Dulcolax (Bisacodyl) may cause side effects in some people, but many people have no side effects or only minor ones.

Common side effects

Common side effects, which happen in more than 1 in 100 people, are:

• feeling sick (nausea)
• diarrhea
• stomach pain or cramps
• stomach cramps
• faintness
• burning in the rectum (for rectal Dulcolax)

These side effects are mild and usually go away after a couple of days. Talk to your doctor or pharmacist if the side effects bother you or don’t go away.

Serious side effects

Call your doctor straight away if these rare side effects happen to you:

• feeling dizzy
• blood in your poo
• rectal bleeding
• being sick (vomiting)

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Dulcolax (Bisacodyl).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Dulcolax (Bisacodyl). For a full list, see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – try taking Dulcolax (Bisacodyl) with some food.
• diarrhea – stop taking Dulcolax (Bisacodyl) and drink plenty of water or other fluids. Speak to a pharmacist if you have signs of dehydration, such as
• peeing less than usual or having dark, strong-smelling pee. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or doctor.
• stomach pain or cramps – reduce your dose of Dulcolax (Bisacodyl) or stop taking it until these side effects go away.

Human Toxicity Reports

Mild to moderate toxicity

• Nausea, vomiting, abdominal pain, and diarrhea have been reported.

Severe toxicity

• Fluid and electrolyte depletion, hypotension from extensive fluid losses, blisters, and skin sloughing of the buttocks and perineum with diarrhea.

Chronic toxicity

• Electrolyte abnormalities (e.g., hypochloremia, hypokalemia, hypocalcemia, hypomagnesemia), reflex bowel hypofunction, permanent colonic dysfunction (cathartic colon, causing chronic constipation, bloating, and abdominal pain), frank/occult gastrointestinal bleeding and associated anemia, steatorrhea, protein-loss gastroenteropathy, pancreatic dysfunction. Toxic hepatitis and jaundice have been reported following the chronic use of very large doses of senna.

In therapeutic oral doses, all stimulant laxatives may produce some degree of abdominal discomfort, nausea, mild cramps, griping, and/or faintness. Rectal administration of bisacodyl suspensions may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis ¹.

Weakness, incoordination, and orthostatic hypotension may be exacerbated in elderly patients as a result of significant electrolyte loss when stimulant laxatives are used repeatedly to evacuate the colon ².

Suppository may produce mild feeling of a sharp stinging pain or tenesmus, and with continued rectal administration may cause proctitis ⁶. Sloughing of surface of epithelium of rectum has been observed. Inflammatory changes that occur after short-term use of bisacodyl suppositories may resemble those seen in mild idiopathic ulcerative proctitis.

Bisacodyl should not be given to patients with intestinal obstruction or acute abdominal conditions such as appendicitis; care should be taken in patients with inflammatory bowel disease. It should not be used in patients with severe dehydration. The suppositories should preferably be avoided in patients with anal fissures, proctitis, or ulcerated hemorrhoids ⁷.

A case report on a female patient with frequent, repetitive formation of kidney stones and rapid double J stent encrustation, which were related to the chronic abuse of bisacodyl. Although these stones can be fragmented successfully by extracorporeal shockwave lithotripsy, it seems that the better treatment for this type of stone formation is to avoid the abuse of laxatives ⁸.

A case report a case of ammonium acid urate stone due to laxative abuse ⁹. A 27-year-old female complained of left flank pain. Computed tomography revealed bilateral ureter stones (right 16.5 x 9.0 mm; left 4 mm), while left ureter stone was radiolucent on the plain X ray film. Bilateral hydronephrosis was seen, but no therapy was performed for the right stone, because 99mTc-MAG3 scintigraphy revealed that right kidney had no function. The left stone was successfully removed by transurethral approach. The stone was revealed to be an ammonium acid urate by infrared spectrophotometry. She had been taking many laxatives (bisacodyl, sennoside, aloe extract) for 12 years to control her body weight ⁹. Ammonium acid urate stones are rarely seen in developed countries. We have reviewed 9 cases in Japan, describing ammonium acid urate stones due to laxative abuse. Among these patients, 24-hour urine volume and excretion in urinary sodium were decreased, and serum aldosterone was increased. The involvement of laxative abuse should be considered when ammonium acid urate is formed in a woman with a low body mass index ⁹.

1. McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 2784[↩][↩][↩][↩]
2. Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1732[↩][↩][↩][↩][↩]
3. Cowl, C.T. Physician’s Handbook 10th edition. Lippincott Williams & Wilkins, Philadelphia, PA. 2003, p. 209[↩]
4. Bisacodyl https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~38hWnu:5[↩][↩]
5. Friedrich C, Richter E, Trommeshauser D et al. Lack of excretion of the active moiety of bisacodyl and sodium picosulfate into human breast milk: an open-label, parallel group, multiple dose study in healthy lactating women. Drug Metab Pharmacokinet. 2011;26:458-64 https://www.jstage.jst.go.jp/article/dmpk/26/5/26_DMPK-11-RG-007/_pdf/-char/en[↩][↩]
6. American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 813[↩]
7. Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 1363[↩]
8. Wu WJ et al; J Formos Med Assoc 92 (11): 1004-6; 1993 https://www.ncbi.nlm.nih.gov/pubmed/7910057[↩]
9. Kato Y et al; Hinyokika Kiyo 50 (11): 799-803; 2004 https://repository.kulib.kyoto-u.ac.jp/dspace/bitstream/2433/113488/1/50_799.pdf[↩][↩][↩]

What is Midol

Midol is a medicine that contains these active ingredients: Acetaminophen 500 mg + Caffeine 60 mg + Pyrilamine maleate 15 mg

Midol is used for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches
• fatigue

Midol active ingredients

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Midol = 120mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ²

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ³.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁴

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁵

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁶

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁴.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁷.

How much caffeine in Midol

• Midol: Acetaminophen 500 mg + Caffeine 60 mg + Pyrilamine maleate 15 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Pyrilamine maleate

Pyrilamine maleate is a histamine H1 antagonist that is often used as an antihistaminergic agent in over-the-counter cold medications ⁸. Pyrilamine maleate selectively binds to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Pyrilamine maleate blocks the effects of histamine and so reduces these symptoms. Pyrilamine maleate acts in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Pyrilamine maleate has mild hypnotic properties and some local anesthetic action and is used for allergies (including skin eruptions) both parenterally and locally. Pyrilamine maleate is also used to induce sleep, prevent sleeplessness, or treat sleep initiation and maintenance disorders. Pyrilamine maleate is a common ingredient of cold remedies.

Alcohol can increase the nervous system side effects of pyrilamine such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with pyrilamine. Do not use more than the recommended dose of pyrilamine, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. Talk to your doctor or pharmacist if you have any questions or concerns.

Midol Important Information

What do I need to tell my doctor before I take Midol?

• If you have an allergy to acetaminophen, caffeine, salicylamide, or any other part of Midol Complete (acetaminophen, caffeine, and pyrilamine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

What are some things I need to know or do while I take Midol?

• Tell all of your health care providers that you take Midol Complete (acetaminophen, caffeine, and pyrilamine). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Midol Complete (acetaminophen, caffeine, and pyrilamine) affects you.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Midol Complete (acetaminophen, caffeine, and pyrilamine) for longer than you were told by your doctor.
• Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
• This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
• Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
• Avoid drinking alcohol while taking Midol Complete (acetaminophen, caffeine, and pyrilamine).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with Midol Complete (acetaminophen, caffeine, and pyrilamine) may cause nervousness, shakiness, and a fast heartbeat.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Midol Complete (acetaminophen, caffeine, and pyrilamine).
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use Midol Complete (acetaminophen, caffeine, and pyrilamine).
• Use with care in children. Talk with the doctor.
• Do not give Midol Complete (acetaminophen, caffeine, and pyrilamine) to a child younger than 12 years old without first checking with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Midol Complete (acetaminophen, caffeine, and pyrilamine) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Midol Complete (acetaminophen, caffeine, and pyrilamine) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using Midol:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

What does Midol do

Midol is used for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches
• fatigue

How is Midol best taken?

Use Midol Complete (acetaminophen, caffeine, and pyrilamine) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food. Take with food if it causes an upset stomach.

How often can you take Midol Complete?

• do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: consult a doctor

What do I do if I miss a dose?

• If you take Midol Complete (acetaminophen, caffeine, and pyrilamine) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Midol Complete (acetaminophen, caffeine, and pyrilamine) is taken on an as needed basis. Do not take more often than told by the doctor.

How long does Midol last?

Midol Complete lasts about 6 hours.

Midol dosage

Midol Complete

Active ingredients (in each caplet): Acetaminophen 500 mg (Pain reliever) + Caffeine 60 mg (Diuretic) + Pyrilamine maleate 15 mg (Antihistamine)

Inactive ingredients: carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert

• acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Midol Complete Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: Ask a doctor

Midol Caffeine Free

Active ingredients (in each caplet): Acetaminophen 500 mg (Pain reliever) + Pamabrom 25 mg (Diuretic)

Pamabrom is a diuretic (water pill). It works by increasing urination.

Pamabrom is used to treat bloating, swelling, feelings of fullness, and other signs of water weight gain related to menstrual symptoms.

Inactive ingredients: carnauba wax, croscarmellose sodium, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Midol Caffeine Free Uses

For the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches

What are some things I need to know or do while I take Midol Caffeine Free?

• Tell all of your health care providers that you take Midol Caffeine Free (acetaminophen and pamabrom). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
• This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
• Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
• Talk with your doctor before you drink alcohol.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Midol Caffeine Free (acetaminophen and pamabrom).
• This medicine is not approved for use in children younger than 12 years old. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Midol Caffeine Free (acetaminophen and pamabrom) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert

• acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Midol Caffeine Free Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: Ask a doctor

What do I do if I miss a dose?

• If you take Midol Caffeine Free (acetaminophen and pamabrom) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Midol Caffeine Free (acetaminophen and pamabrom) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Other side effects of Midol Caffeine Free

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Midol Long Lasting Relief

Active ingredients (in each caplet): Acetaminophen 650 mg (Pain reliever)

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Midol Long Lasting Relief Uses

Temporarily relieves minor aches and pains due:

• Temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• Temporarily reduces fever

Liver warning

The product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if you have liver disease.

Allergy Alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
• If you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition

As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

If pregnant or breast-feeding, ask a health professional before use.

Midol Long Lasting Relief Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• Children under 12 years: Ask a doctor

Midol side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Rare side effects

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Midol Overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

1. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.[↩]
2. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.[↩]
3. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/[↩]
4. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.[↩][↩]
5. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.[↩]
6. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information[↩]
7. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/[↩]
8. Pyrilamine maleate. https://pubchem.ncbi.nlm.nih.gov/compound/pyrilamine_maleate[↩]

What is Colace

Colace is an emollient laxative medicine that is used to treat constipation (difficulty pooing). Colace contains the active ingredient Docusate. Colace (Docusate) helps to soften your poo (stool softener) and makes your bowel movements easier to pass.

Colace (Docusate) is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements. Colace (Docusate) may also be used for purposes not listed in this medication guide.

Colace (Docusate) is helpful when you have difficulty going to the toilet because of dry poos or piles (hemorrhoids) or if you have a tear in the lining of your back passage (an anal fissure). Colace (Docusate) makes your bowel movements softer and easier to pass.

You may also be given Colace (Docusate) if you’re going to have an x-ray of your stomach. It can help you empty your bowels beforehand.

Colace (Docusate) comes as capsules and as a liquid that you swallow. Colace (Docusate) also comes as an enema – a tube of liquid medicine which you squeeze into your back passage.

Colace (Docusate) is available on prescription. You can also buy it from pharmacies.

Key facts

• Colace (Docusate) capsules and liquid take 1 or 2 days to work.
• The Colace (Docusate) enema usually works within 20 minutes – so it’s best to stay close to a toilet.
• Do not give Colace (Docusate) to a child under 12 years old unless their doctor prescribes it.
• Do not take Colace (Docusate) for more than a week without talking with your doctor.
• Docusate is also known by the brand names Surfak, Dulcoease, Dioctyl,Diocto, Dioeze, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docuprene, Docusil, Docusoft S, DocuSol, DOK, DSS, Dulcolax Stool Softener, Enemeez Mini, Kao-Tin, Octycine-250, Pedia-Lax Stool Softener, Phillips Stool Softener, Promolaxin, Silace, Surfak Stool Softener, Sur-Q-Lax, Vacuant. The enema is known by the brand name Norgalax.

Colace mechanism of action

Colace (Docusate) stool softener (emollient laxative) encourages bowel movements by helping water and fats to get into the stool and prevent dry, hard stool masses. This type of laxative has been said to allow patient to have a bowel movement without straining.

Colace (Docusate) is not a stimulant laxative.

How long does it take for Colace to work?

Colace (Docusate) capsules and liquid normally take 1 or 2 days to work. The enema usually works within 20 minutes, so it’s best to stay close to a toilet.

Talk to your doctor or pharmacist if you are still constipated after a week.

How long should I take Colace for?

Take Colace (Docusate) for up to 1 week. If you take Colace (Docusate) for longer, your bowel can start to rely on it, rather than working on its own.

If you are still constipated after taking Colace (Docusate) for a week, talk to your doctor.

If your constipation is caused by an illness or a medicine you’re taking, your doctor will advise you about when it’s best to stop taking Colace (Docusate).

Is it safe to take Colace for a long time?

Ideally, you should only use Colace (Docusate) occasionally and for a few days at a time.

Using laxatives like Colace (Docusate) for longer can lead to long term diarrhea. They can also cause an electrolyte imbalance. This means that levels of substances like sodium, potassium and magnesium in your body get too high or too low. A severe electrolyte imbalance can cause serious health problems such as muscle spasm and twitching, and even fits (convulsions).

Using Colace (Docusate) for many weeks, even months, could also stop your bowel working properly on its own.

Can I take different laxatives together?

For most people, 1 laxative will be enough to relieve constipation.

Occasionally, you may need to take 2 different types of laxatives at the same time to get your bowels moving again.

Only take 2 laxatives together on the advice of your doctor or pharmacist as there is an increased risk of side effects.

Are other laxatives any better?

There are other types of laxative. They work in a different way to Colace (Docusate) but are equally good at treating constipation.

• Bulk-forming laxatives, for example Fybogel and methylcellulose. These increase the ‘bulk’ or weight of poo which in turn stimulates bowel movement. They take 2 or 3 days to work.
• Osmotic laxatives, for example lactulose. These draw water from the rest of the body into your bowel to soften your poo and make it easier to pass. They take at least 2 days to work.
• Stimulant laxatives, for example senna. These stimulate the muscles that line your gut, helping them to move poo along your gut to your back passage. Senna takes about 8 hours to work.

Is there any food and drink I need to avoid?

You can eat and drink normally while taking Colace (Docusate).

It might be a good idea to stop eating pastries, puddings, sweets, cheese and cake for a while as these foods can make constipation worse.

Can I drink alcohol with Colace?

Yes, you can drink alcohol with Colace (Docusate).

Can I use Colace after surgery?

It’s quite common to have constipation after surgery. Using a laxative may help relieve the discomfort.

If you have constipation after an operation, it’s better to use lactulose because it is gentler than Colace (Docusate). You can get it from pharmacies.

Can lifestyle changes help constipation?

It’s often possible to improve constipation without having to use laxatives. Before trying Colace (Docusate) – or to stop constipation coming back – it may help to:

• eat more fiber – aim for about 30-35 g of fiber a day. High-fiber foods include fruit, vegetables and cereals. If you’re not used to a high-fiber diet, increase the amount of fiber you eat gradually.
• add bulking agents, such as wheat bran, to your diet. These will help make your poo softer and easier to pass (although bran and fiber can sometimes make bloating worse).
• drink plenty of water – to keep poo soft
• exercise regularly – keeping your body active will help to keep your gut moving

Who can and can’t take Colace

Most adults can safely take Colace (Docusate), but do not give it to a child under 12 years old unless their doctor prescribes it.

• Never give Colace (Docusate) to a child under 12 years old unless their doctor prescribes it.

Colace (Docusate) isn’t suitable for some people. To make sure it is safe for you, tell your doctor or pharmacist if you have:

• ever had an allergic reaction to Colace (Docusate) or any other medicines in the past
• ever had an allergic reaction to fructose or sorbitol (types of sugar)
• a blockage in your gut (intestine)
• chronic stomach pain that has not been checked by a doctor
• nausea, vomiting, or severe stomach pain
• stomach pains
• been feeling sick in the last 24 hours or have been sick
• been taking a mineral oil laxative such as liquid paraffin

Ask a doctor or pharmacist if it is safe for you to take Colace (Docusate):

• if you are on a low-salt diet; or
• if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

Do not use an enema containing Colace (Docusate) if you have:

• piles (hemorrhoids) or bleeding from your back passage
• sores around your back passage called anal fissures
• illnesses where your bowel or back passage become inflamed such as ulcerative colitis or Crohn’s disease
• ileus – when the muscles in your bowel aren’t able to move food and liquid along

Pregnancy and breastfeeding

Tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

It is not known whether Colace (Docusate) will harm an unborn baby. Do not use this medicine without a doctor’s advice if you are pregnant.

Colace (Docusate) may not be suitable if you’re pregnant or breastfeeding because small amounts might be absorbed by your gut.

If you’re pregnant or breastfeeding, it’s always better to try to treat constipation without taking a medicine. Your doctor or midwife will first advise you to eat more fiber and drink plenty of fluids. It may also help to do gentle exercise.

If diet and lifestyle changes don’t work, your doctor or midwife may recommend a laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

I just found out I am pregnant. Should I stop taking Colace?

You should always talk with your health care provider before making any changes in your medication. It is important to consider the benefits of treating constipation symptoms during pregnancy. Your health care provider may also want to confirm diagnosis of constipation and see how dietary and other lifestyle therapies may help.

Can use of Colace during pregnancy cause birth defects?

Few studies have been done to look at the possible risks of Colace (Docusate) during pregnancy. However, the available studies show that when used in recommended doses Colace (Docusate) is not expected to increase the chance of birth defects.

In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk.

What if the father of the baby takes Colace?

There are no studies looking at possible problems with conceiving or risks to a pregnancy when the father takes Colace (Docusate). In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

What are the dangers of taking too much Colace sodium?

When used in recommended doses, Colace (Docusate) is unlikely to cause problems during pregnancy. However, when more than the recommended amount of this product is used, it can lower the levels of magnesium in a person’s blood. There is one reported case of low magnesium levels in a newborn that was linked to the mother overusing Colace (Docusate). The baby’s main symptom was jitteriness, which went away by the second day of life. There have been no reported problems linked to the use of recommended levels of Colace (Docusate) in pregnancy.

Colace and breastfeeding

It is not known whether Colace (Docusate) passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

While some of the Colace (Docusate) is absorbed by the mother, the amount that passes into milk is likely low ¹. There have been no reports of problems in babies that are breastfeeding while the mother is taking Colace (Docusate). Be sure to talk to your health care provider about all your choices for breastfeeding.

In a randomized, blinded trial, 35 postpartum breastfeeding patients received a laxative containing docusate in a dose of 120 mg daily in addition to danthron 100 mg daily. One patient stated that diarrhea occurred in her breastfed infant ². The diarrhea was most likely caused by the danthron. Danthron is a reddish, synthetic anthraquinone derivative ³. Danthron has been widely used as a laxative, but is no longer used to treat constipation and is currently used as an antioxidant in synthetic lubricants, in the synthesis of experimental antitumor agents, as a fungicide and as an intermediate for making dyes.

If diet and lifestyle changes don’t work, your doctor or midwife may recommend a laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

Cautions with other medicines

Do not take docusate with a mineral oil laxative such as liquid paraffin.

What is Colace used for

Colace (Docusate) is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements. Colace (Docusate) may also be used for purposes not listed in this medication guide.

Colace (Docusate) is helpful when you have difficulty going to the toilet because of dry poos or piles (hemorrhoids) or if you have a tear in the lining of your back passage (an anal fissure). Colace (Docusate) makes your bowel movements softer and easier to pass.

You may also be given Colace (Docusate) if you’re going to have an x-ray of your stomach. It can help you empty your bowels beforehand.

• Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
• Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace vs Dulcolax

Dulcolax contains the active ingredient Bisacodyl, is a laxative that stimulates bowel movements. Bisacodyl acts by directly stimulating the nerve endings in the mucosa of the colon, increasing the movement of the intestines.

Dulcolax (Bisacodyl) is used to treat constipation or to empty the bowels before surgery, colonoscopy, x-rays, or other intestinal medical procedure. Dulcolax (Bisacodyl) tablets generally produce a bowel movement in 6 to 12 hours.

Dulcolax (Bisacodyl) is used in hospitals to help you empty your bowels before surgery or some examinations or treatments. Your hospital will explain how to use it.

Dulcolax (Bisacodyl) comes as a tablet and a suppository (a medicine that you push gently into your back passage).

The tablets and suppositories are available on prescription and to buy from pharmacies.

Dulcolax (Bisacodyl) may be given as follows:

• Usual Adult Dose for Constipation
  • 5 to 15 mg (1 to 3 tablets) orally once a day as needed or
  • 10 mg (1 suppository) rectally once a day as needed or
  • 10 mg rectal liquid once a day as needed.
• Usual Adult Dose for Bowel Preparation
  • 5 to 15 mg (1 to 3 tablets) orally once a day as needed or
  • 10 mg (1 suppository) rectally once a day as needed or
  • 10 mg rectal liquid once a day as needed.

Elderly patients taking Dulcolax (Bisacodyl) have an increased risk of fecal incontinence.

Dulcolax (Bisacodyl) can be used during lactation however, it should only be used occasionally during pregnancy

The onset of action of Dulcolax (Bisacodyl) is as follows:

• Oral: 6-12 hours
• Suppository: 15-60 minutes
• Enema: 5-15 minutes

How and when to take Colace

Colace (Docusate) comes as capsules, liquid and an enema.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

• Do not crush, chew, break, or open a Colace (Docusate) capsule or tablet. Swallow it whole.
• Colace (Docusate) should generally be used for a period of less than 1 week. For longer than one week see your doctor for advice.
  

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking Colace (Docusate).

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.

After taking Colace (Docusate) by mouth (tablets, capsules, liquid), you should have a bowel movement within 12 to 72 hours.

• Do not take Colace (Docusate) Rectal Enema by mouth. It is for use only in your rectum.

Wash your hands before and after using Colace (Docusate) enema.

Try to empty your bowel and bladder just before using the enema. Remove the cap from the enema applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it. For best results, hold in the enema for as long as possible, or until you have a bowel movement.

The rectal enema should produce a bowel movement within 2 to 15 minutes.

Do not use Colace (Docusate) for longer than 7 days unless your doctor has told you to. Call your doctor if your symptoms do not improve, or if you have not had a bowel movement within 1 to 3 days. Overuse of a stool softener can lead to serious medical problems.

Store at room temperature away from moisture and heat.

How to take Colace

• Capsules – swallow the capsule whole with plenty of water.
• Liquid – this comes with a plastic cup or spoon to measure the dose. Do not use a kitchen spoon as it will not give the right amount. If you don’t have a cup or spoon, ask your pharmacist for one. When you’ve swallowed it, drink plenty of water or another drink, such as milk or orange juice.
• Enema – squeeze the tube of liquid gently into your back passage. The information leaflet which comes with your Colace (Docusate) will explain how to do this.

Colace (Docusate) doesn’t usually upset your tummy. You can take the capsules or liquid with or without food. Try to take them at regular intervals throughout the day. Mealtimes (breakfast, lunch and dinner) are useful reminders.

There is no specific time of day to use an enema but it works quickly (usually between 5 and 20 minutes), so use it when you know you’ll be near a toilet.

How much to take

• Capsules – the normal dose is 1 capsule 3 times a day. Do not take more than 5 capsules in a day.
• Liquid – the normal dose is 2 or 3 x 5ml spoonfuls. Take this dose 3 times a day.
• Enema – normally 1 tube of liquid is all you need. If you need a second dose, you can use it later in the day or the next day.

You should feel more comfortable within 1 or 2 days of treatment. Reduce the dose as your condition gets better.

Drink plenty of fluids (6 to 8 glasses a day) while you are taking Colace (Docusate) or your constipation may get worse.

Usual Adult Dose for Constipation

• Oral: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.
• Rectal: 200 to 283 mg rectally administered as an enema once or twice.
• Alternative: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.

Usual Pediatric Dose for Constipation

• Oral:
  • less than 3 years: 10 to 40 mg (docusate sodium) orally divided in 1 to 4 doses.
  • 3 to 6 years: 20 to 60 mg (docusate sodium) orally divided in 1 to 4 doses.
  • 6 to 12 years: 40 to 150 mg (docusate sodium) orally divided in 1 to 4 doses.
  • older than 12 years: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.
• Rectal:
  • 3 to 18 years: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.
  • Alternative: 200 to 283 mg rectally administered as an enema once daily as needed for constipation.

Renal Dose Adjustments

• Data not available

Liver Dose Adjustments

• Data not available

Kidney Dialysis

• Data not available

What if I forget to take it?

If you forget a dose of Colace (Docusate), don’t worry, just take the next dose as normal.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

What if I take too much?

Taking an extra dose of Colace (Docusate) by accident is unlikely to harm you but you should drink lots of water. You may get diarrhoea and stomach pain but this should ease off within a day or two.

If you’re worried, talk to your doctor or pharmacist for advice.

Colace dosage

Colace Regular Strength

Colace Regular Strength Warnings

• Do not use laxative products for longer than 1 week unless told to do so by a doctor.
• Do not use if you are presently taking mineral oil unless told to do so by a doctor.
• Ask a doctor before use if you have:
  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over two weeks
• Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• If pregnant or breastfeeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace Regular Strength Uses

• Treat occasional constipation – including constipation associated with certain medical conditions – safely, gently, and effectively with Colace Capsules.
• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for comfortable relief
• Generally produces bowel movement in 12 to 72 hours

Colace Regular Strength Directions of Use

• Take only by mouth. May be taken as a single daily dose or in divided doses.
• Adults and children 12 years of age and over: 1 to 3 capsules daily
• Children 2 to under 12 years of age: 1 capsule daily
• Children under 2 years: Ask a doctor

Colace Clear

Colace Clear is a stool softener available in a clear formulation that is dye-free and a lower strength. Use Colace Clear to treat occasional constipation, including constipation associated with certain medical conditions.

• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for those who have conditions where they should avoid straining
• Dye-free
• Generally produces bowel movement in 12 to 72 hours

Colace Clear Warnings

• Do not use laxative products for longer than 1 week unless told to do so by a doctor.
• Do not use if you are presently taking mineral oil unless told to do so by a doctor.
• Ask a doctor before use if you have:
  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over two weeks
• Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• If pregnant or breastfeeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace Clear Uses

• Treat occasional constipation – including constipation associated with certain medical conditions – safely, gently, and effectively with Colace Capsules.
• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for comfortable relief
• Generally produces bowel movement in 12 to 72 hours

Colace Regular Strength Directions of Use

• Take only by mouth. May be taken as a single daily dose or in divided doses.
• Adults and children 12 years of age and over: 1 to 6 capsules daily
• Children 2 to under 12 years of age: 1 to 3 capsules daily
• Children under 2 years: Ask a doctor

Colace side effects

Like all medicines, Colace (Docusate) may cause side effects in some people but most people have no side effects or only minor ones.

If you get any of these side effects, talk to your doctor or pharmacist:

• feeling sick
• diarrhea
• stomach cramps
• dizziness, weakness
• gas, bloating, mild diarrhea
• rectal irritation
• sweating

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

These side effects are mild and usually go away after a couple of days.

With the Colace (Docusate) enema sometimes people get a burning or pain around their back passage. Occasionally the wall of the back passage may bleed. This is a reaction to the enema and it should clear up quickly. If the pain or bleeding don’t go away or you are worried about them, talk to your doctor or pharmacist.

Stop using Colace (Docusate) and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• rectal bleeding or irritation;
• numbness or a rash around your rectum;
• vomiting, severe diarrhea or stomach cramps; or
• continued constipation, or no bowel movement.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal cramping. Reports of bitter taste and throat irritation have been reported with administration of primarily the syrup and liquid formulations.

Dermatologic

Dermatologic side effects have included rash.

Metabolic

Metabolic side effects have included at least one case report of hypomagnesemia.

Metabolic abnormalities reported include hypomagnesemia in one woman who took docusate chronically throughout her pregnancy. Magnesium levels returned to normal following discontinuation of Colace (Docusate).

Serious side effects

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Colace (Docusate).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Colace (Docusate). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – try taking Colace (Docusate) with meals or mixing your dose with some water or fruit juice.
• diarrhea – drink plenty of water or other fluids. It may also help to take an oral rehydration drink to prevent dehydration. You can buy sachets of powder from a pharmacy which you mix with water. Reducing the dose of Colace (Docusate) may also help diarrhea. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or doctor.
• stomach cramps – if you get stomach cramps, reduce your dose of Colace (Docusate) until it goes away.

1. Lewis JH, Weingold AB and the Committee of FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80:912-23 https://www.ncbi.nlm.nih.gov/pubmed/2864852[↩]
2. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210:259-63 https://www.ncbi.nlm.nih.gov/pubmed/4570522[↩]
3. Danthron. https://pubchem.ncbi.nlm.nih.gov/compound/danthron[↩]

What is Allegra

Allegra is an antihistamine that relieves the symptoms of allergies. Allegra contain an active ingredient called Fexofenadine, which is known as a non-drowsy antihistamine (a second generation antihistamine). Allegra (Fexofenadine) is much less likely to make you feel sleepy than some other antihistamines. Allegra (Fexofenadine) is a histamine [H1] receptor blocker, it works by blocking the action of histamine, a substance in the body that causes allergic symptoms. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Allegra (Fexofenadine) blocks the effects of histamine and so reduces these symptoms.

Allegra (Fexofenadine) is used to treat hay fever (seasonal allergic rhinitis), allergic conjunctivitis (red, itchy eye), itchy throat, eczema and hives of the skin (nettle rash or chronic idiopathic urticaria). Allegra (Fexofenadine) is also used for reactions to insect bites and stings and for some food allergies.

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. It’s less likely to make you feel sleepy than some other antihistamines.

Allegra (Fexofenadine) is available is an over-the- counter (OTC) and also on prescription. It comes as tablets, meltable tablets, capsule and liquid suspension

Key facts

• It’s usual to take Allegra (Fexofenadine) once a day. Children sometimes take it twice a day.
• Allegra (Fexofenadine) is classed as a non-drowsy antihistamine, but some people still find it makes them feel quite sleepy.
• Common side effects include headache, feeling sleepy, dry mouth, feeling sick and dizziness.
• Don’t drink grapefruit juice, apple juice or orange juice while you’re taking Allegra (Fexofenadine). It might make you more likely to get side effects.
• It’s best not to drink alcohol while you’re taking Allegra (Fexofenadine) as it can make you feel sleepy.
• Fexofenadine is also called by the brand name Telfast, Allegra and Allegra ODT

What is Allegra used for?

Allegra (Fexofenadine) is used to relieve the allergy symptoms of seasonal allergic rhinitis (”hay fever”), including runny nose; sneezing; red, itchy, or watery eyes (allergic conjunctivitis); itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), eczema including itching and rash in adults and children 6 months of age and older.

Allegra (Fexofenadine) is also used for reactions to insect bites, stings, some food allergies and a condition called chronic idiopathic urticaria in adults and children.

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. It’s less likely to make you feel sleepy than some other antihistamines.

How long does it take for Allegra to work?

You should start to feel better within an hour or 2.

What’s the difference between Allegra and other antihistamines?

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. That’s because it’s less likely to make you feel sleepy than other, so-called ‘sedating antihistamines’ such as Benadryl (Diphenhydramine).

Most people prefer to take a non-drowsy antihistamine instead of a sedating one. An exception is when you want the medicine to make you sleepy, for example if you have itchy skin that’s keeping you awake at night.

What’s the difference between Allegra and other non-drowsy antihistamines?

Other non-drowsy antihistamines like acrivastine, cetirizine (Zyrtec), loratadine (Claritin), desloratadine and levocetirizine seem to work just as well as Allegra (Fexofenadine).

However, Allegra (Fexofenadine) seems to be less likely to make you feel sleepy than other non-drowsy antihistamines.

If one non-drowsy antihistamine hasn’t worked for you, it’s worth trying another one.

How long should I take Allegra for?

It depends on why you’re taking Allegra (Fexofenadine).

You may only need to take it as a one-off dose or for a day or 2, for example if you have a reaction to an insect bite.

You may need to take Allegra (Fexofenadine) for longer if you’re taking it to prevent symptoms – for example, to stop hay fever when the pollen count is high.

Talk to your doctor or pharmacist if you’re unsure how long you need to take Allegra (Fexofenadine) for.

Is it safe to take Allegra for a long time?

Allegra (Fexofenadine) is unlikely to do you any harm if you take it for a long time. However, it’s best to take Allegra (Fexofenadine) only for as long as you need to.

Can I drive or ride a bike with Allegra?

Allegra (Fexofenadine) is classed as a non-drowsy antihistamine but it’s still possible to feel sleepy after taking it.

If you’re taking Allegra (Fexofenadine) for the first time, see how it makes you feel before driving, cycling or using heavy machinery or tools.

Does Allegra (Fexofenadine) cause weight gain?

Allegra (Fexofenadine) isn’t known to cause weight gain.

Can I take Allegra with painkillers?

Yes, you can take Allegra (Fexofenadine) together with acetaminophen (Tylenol) or ibuprofen (Motrin).

Can I take more than one antihistamine together?

Sometimes doctors recommend that people with a severe itchy skin rash take 2 different antihistamines together for a few days.

As well as taking a non-drowsy antihistamine during the day such as Allegra (Fexofenadine), Zyrtec (Cetirizine) or Claritin (Loratadine), your doctor may suggest that you take a sedating antihistamine (e.g. Benadryl) at night time if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless your doctor advises you to.

Can I take Allegra with other hay fever treatments?

Yes, it’s fine to take Allegra (Fexofenadine) together with other hay fever treatments, for example steroid nasal sprays (such as Beconase, Rhinacort Aqua and Flixonase Nasules) or eye drops.

Can I take Allegra at higher doses than on the packet?

Your doctor might suggest you or your child take a higher dose of Allegra (Fexofenadine) (up to 4 times the usual dose) for a severe itchy skin rash or angioedema (swelling underneath the skin).

Taking high doses of Allegra (Fexofenadine) isn’t suitable for everyone. Speak to your doctor if you don’t think Allegra (Fexofenadine) is working for you.

Can lifestyle changes relieve hay fever?

It will help if you don’t spend too much time outside if the pollen count is high.

Tips for when you’re outside:

• Don’t cut grass or walk on grass.
• Wear wraparound sunglasses to stop pollen getting into your eyes.
• Put Vaseline around your nostrils to help trap pollen.
• Shower and change your clothes after you’ve been outside to wash off pollen.

Tips for when you’re inside:

• Keep windows and doors shut as much as possible.
• Vacuum regularly and dust with a damp cloth.
• Don’t keep fresh flowers in the house.
• Don’t smoke or be around smoke as it makes hay fever symptoms worse.

Who can and can’t take Allegra

Allegra (Fexofenadine) tablets can be taken by adults and children aged 6 years and over.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered.

Allegra (Fexofenadine) isn’t recommended for people over 65 years old because there isn’t much research on the medicine in this age group. Talk to your pharmacist or doctor if you’re over 65 and want to take Allegra (Fexofenadine). Elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving Allegra (Fexofenadine).

Allegra (Fexofenadine) isn’t suitable for some people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to Allegra (Fexofenadine) or any other medicines in the past. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
• have problems with your liver or kidneys
• have, or have ever had, heart problems
• have epilepsy or another health problem that puts you at risk of seizures
• are booked to have an allergy test – taking Allegra (Fexofenadine) may affect the results, so you might need to stop taking it a few days before the test

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
• Phenylketonuria—Use with caution. The oral disintegrating tablets contain phenylalanine .

Pediatric patients

Appropriate studies have not been performed on the relationship of age to the effects of Allegra (Fexofenadine) in children below 6 months of age. Safety and efficacy have not been established.

• Do NOT give Allegra (Fexofenadine) to a child without medical advice.

Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

Allegra Drug Interactions

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Some medicines and Allegra (Fexofenadine) interfere with each other and increase the chances of you having side effects. Check with your pharmacist or doctor if you’re taking:

• midodrine, a medicine used to treat low blood pressure
• ketoconazole, a medicine to treat fungal infections
• erythromycin, an antibiotic
• ritonavir or lopinavir, medicines used to treat HIV infection
• rifampicin, an antibiotic
• indigestion remedies containing aluminium or magnesium – leave about 2 hours between the times that you take Allegra (Fexofenadine) and your indigestion remedy
• any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to pee. Taking Allegra (Fexofenadine) might make these side effects worse.

Using Allegra (Fexofenadine) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Eliglustat
• Simeprevir

Using Allegra (Fexofenadine) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• St John’s Wort

Mixing Allegra with herbal remedies and supplements

There might be a problem taking some herbal remedies and supplements alongside Allegra (Fexofenadine) – especially ones that cause sleepiness, a dry mouth or make it difficult to pee.

Ask your pharmacist for advice.

Can I drink alcohol with Allegra?

It’s best not to drink alcohol while you’re taking Allegra (Fexofenadine) as it can make you feel sleepy.

Is there any food or drink I need to avoid?

Don’t drink grapefruit juice, orange juice or apple juice while taking Allegra (Fexofenadine). It might make you more likely to have side effects.

Fruit juices can make it harder for your body to absorb Allegra (Fexofenadine). Do not take Allegra with fruit juice (such as apple, orange, or grapefruit).

What else should I avoid?

Avoid using antacids within 15 minutes before or after taking a medication that contains Allegra. Antacids can make it harder for your body to absorb this medication.

Avoid taking any other cold or allergy medicines unless your doctor has told you to.

Pregnancy and Breastfeeding

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Allegra (Fexofenadine) isn’t normally recommended during pregnancy.

FDA pregnancy category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

It is not known whether Allegra (Fexofenadine) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

A similar antihistamine called Loratadine (Claritin) is normally used first because there’s more information to say that it’s safer.

Talk to your doctor about the benefits and possible harms of taking Allegra (Fexofenadine). It will also depend on how many weeks pregnant you are and the reason you need to take Allegra (Fexofenadine).

I just found out I am pregnant. Should I stop taking Allegra?

You should always talk with your healthcare provider before making any changes in your medications. It is important to consider the benefits of treating allergy symptoms and other conditions during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for additional asthma medicines.

In people who took 60 mg of Allegra (Fexofenadine) twice a day, it could take up to 4 days for all of this medication to leave the body.

I am pregnant. Can use of Allegra during pregnancy cause birth defects?

So far, studies on both Allegra (Fexofenadine) and Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] have not found an increase in birth defects with use of these medicines ¹, ², ³, ⁴, ⁴, ⁵.

Can Allegra cause a miscarriage?

There are no studies that have looked at whether Allegra (Fexofenadine) can increase the chance for a miscarriage.

Can use of Allegra cause other pregnancy complications?

No studies have looked at whether Allegra (Fexofenadine) could cause other pregnancy complications. A study on Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] found no increase in premature delivery or low birth weight with use during pregnancy.

Will Allegra affect my fertility?

There’s no evidence that Allegra (Fexofenadine) affects male or female fertility.

Will Allegra affect my contraception?

Allegra (Fexofenadine) doesn’t affect any type of contraception, including the contraceptive pill and the morning after pill.

What if the father of the baby takes Allegra?

There is no evidence that suggests that a man’s Allegra (Fexofenadine) use would cause any problems during his partner’s pregnancy. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Allegra (Fexofenadine) and breastfeeding

There’s not a lot of information on the use of Allegra (Fexofenadine) during breastfeeding, and so it’s best not to take it.

• Allegra (Fexofenadine) during breastfeeding is not recommended.

It’s usually safe to take similar antihistamines called Loratadine (Claritin) and Cetirizine (Zyrtec) while you’re breastfeeding.

However, speak to your doctor before taking any antihistamine if your baby was premature, had a low birth weight or has other health problems.

It is not known if fexofenadine hydrochloride is distributed into breast milk ⁶. Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, the manufacturer states that fexofenadine alone or in fixed combination with pseudoephedrine hydrochloride should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman ⁶.

Allegra (Fexofenadine) is less likely to cause sleepiness in adults than some other antihistamines. For this reason, Allegra (Fexofenadine) may be preferred for breastfeeding over antihistamines that do cause sleepiness. Information from Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] suggests that the amount of Allegra (Fexofenadine) in the breastmilk is small. One study estimated that a baby that was breastfed by a mother taking Allegra (Fexofenadine) got less than 1% of the mother’s dose ⁷. This dose would be too low to cause problems for the baby.

When 25 women were asked by telephone how their babies were doing while they were taking terfenadine and breastfeeding, three mothers said their babies experienced irritability but that they did not need to take the babies to a healthcare provider ⁸. It is not possible to know if their irritability was caused by terfenadine in breastmilk.

It is possible, but not proven, that antihistamines may lower the amount of milk a woman makes. This might be more likely to occur if antihistamines are used in combination with an oral decongestant like pseudoephedrine or phenylephrine, or if used before beginning to breastfeed.

Be sure to talk to your health care provider about all your breastfeeding questions.

Allegra vs Zyrtec

Zyrtec (Cetirizine) is also classed as a non-drowsy antihistamine medicine that relieves the symptoms of allergies by blocking the effects of the chemical histamine in your body. But Allegra (Fexofenadine) seems to be less likely to make you feel sleepy than Zyrtec (Cetirizine).

Zyrtec’s active ingredient is a compound called Cetirizine (IUPAC name: 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid) which is a non-drowsy antihistamine ⁹. Zyrtec (cetirizine) was the first marketed drug from the series of second-generation antihistamines showing both minimal side effects on the central nervous system and a reduced level of cardiotoxicity ⁹. Zyrtec (cetirizine) is much less likely to make you feel sleepy than some other first generation or older antihistamines.

Zyrtec (cetirizine) is used to treat hay fever or allergy symptoms such as allergic conjunctivitis (red, itchy eye), eczema and hives. It’s also used for reactions to insect bites and stings and for some food allergies and the symptoms of common cold.

How and when to take Allegra

If you or your child have been prescribed Allegra (Fexofenadine), follow your doctor’s instructions about how and when to take it.

Before taking Allegra – Precautions

• tell your doctor and pharmacist if you are allergic to Allegra (Fexofenadine), any other medications, or any of the ingredients in Allegra (Fexofenadine) tablets or suspension. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention either of the following: erythromycin (E.E.S., E-Mycin, Erythrocin) and ketoconazole (Nizoral). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking an antacid containing aluminum or magnesium (Maalox, Mylanta, others), take the antacid a few hours before or after Allegra (Fexofenadine).
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Allegra (Fexofenadine), call your doctor.

How should Allegra be used?

Allegra (Fexofenadine) comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken with water once or twice a day. Allegra (Fexofenadine) will work better if it is not taken with fruit juices such as orange, grapefruit, or apple juice. Take Allegra (Fexofenadine) at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Allegra (Fexofenadine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Allegra (Fexofenadine) controls the symptoms of seasonal allergic rhinitis and urticaria but does not cure these conditions. Continue to take Allegra (Fexofenadine) even if you feel well and are not experiencing these symptoms. If you wait too long between doses, your symptoms may become worse.

Shake the suspension well before each use to mix the medication evenly.

How much should I take?

Allegra (Fexofenadine) comes as tablets (30mg, 120mg and 180mg).

How much you take depends on why you’re taking Allegra (Fexofenadine):

• For hay fever – the usual dose for adults and children aged 12 years and over is 120mg once a day. The usual dose for children aged 6 to 11 years is 30mg twice a day. In this case, try to space the doses 10 to 12 hours apart.
• For hives (nettle rash) – the usual dose for adults and children aged 12 years and over is 180mg once a day.

Allegra (Fexofenadine) Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For symptoms of hay fever:

• For oral dosage form (capsules, tablets):
  • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  • Children 6 to 11 years of age—30 mg two times a day.
  • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  • Children and infants up to 4 years of age—Use is not recommended.
• For oral dosage form (disintegrating tablets):
  • Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  • Children and infants up to 4 years of age—Use is not recommended.
• For oral dosage form (suspension):
  • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.

For symptoms of chronic hives:

• For oral dosage form (capsules, tablets):
  • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  • Children 4 to 11 years of age—30 mg two times a day.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (disintegrating tablets):
  • Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (suspension):
  • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  • Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day.
  • Children younger than 6 months of age—Use and dose must be determined by your doctor.

How to take Allegra

• If you’re taking 30mg Allegra (Fexofenadine) tablets, you can take them with or without food.
• If you’re taking 120mg and 180mg Allegra (Fexofenadine) tablets, take them before a meal.

Always take your Allegra (Fexofenadine) tablets with a drink of water. Swallow them whole – do not chew them.

Do NOT take Allegra (Fexofenadine) with juice such as grapefruit, orange, or apple juice.

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist .

For patients using the oral disintegrating tablet form of Allegra:

• Make sure your hands are dry.
• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
• Immediately place the tablet on top of the tongue. Do not chew or break the tablet.
• The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved.
• Always take this tablet on an empty stomach.

Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup.

When to take Allegra

You may only need to take Allegra (Fexofenadine) on a day you have symptoms, such as if you’ve been exposed to something you’re allergic to like animal hair. Or you may need to take it regularly to prevent symptoms, such as to stop hay fever during spring and summer.

What if I forget to take it?

If you’re taking Allegra (Fexofenadine) once a day, do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time as prescribed by your doctor.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Allegra (Fexofenadine) is generally very safe. Taking too much is unlikely to harm you.

If you take an extra dose by mistake, you might get some of the common side effects. If this happens or you’re concerned, contact your doctor.

Allegra dosage

Allegra 12HR

Active ingredient: Fexofenadine HCI 60 mg in each tablet (Antihistamine)

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Other information

• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Protect from excessive moisture.

Allegra 12HR Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Allegra 12HR Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Allegra 12HR Directions of Use

• Adults and children 12 years of age and over: Take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
• Children under 12 years of age: do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Allegra 24HR

Active ingredient: Fexofenadine HCI 180 mg in each tablet (Antihistamine)

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Other information

• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Protect from excessive moisture.

Allegra 24HR Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Allegra 24HR Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Allegra 24HR Directions of Use

• Adults and children 12 years of age and over: Take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours.
• Children under 12 years of age: do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Children’s Allegra Liquid

Active ingredient: Fexofenadine HCI 30 mg in each 5 mL teaspoonful (Antihistamine)

Inactive ingredients: butylparaben, edetate disodium, flavor, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Other information

• Each 5 mL teaspoon contains: sodium 18 mg
• Safety sealed: Do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
• Store between 20˚ and 25˚C (68˚ and 77˚F).

Children’s Allegra Liquid Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Allegra Liquid Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Allegra Liquid Directions of Use

• Shake well before using. Use only with enclosed dosing cup.
• One dose lasts a full 12 hours. See carton for dosing instructions. Use only as directed.
• Adults and children 12 years of age and over: Take 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours
• Children 2 to under 12 years of age: Take 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (10 mL) in 24 hours
• Children under 2 years of age: Ask a doctor
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Children’s Allegra Meltable Tablets

Active ingredient: Fexofenadine HCI 30 mg in each tablet (Antihistamine)

Inactive ingredients: aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

Other information

• Each tablet contains: sodium 3.8 mg
• Phenylketonurics: contains phenylalanine 5.3 mg per tablet
• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Use tablet immediately after opening individual blister.
• Contains lactose.

Children’s Allegra Meltable Tablets Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Allegra Meltable Tablets Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Allegra Meltable Tablets Directions of Use

• Place 1 tablet on tongue; tablet disintegrates with or without water.
• One dose lasts a full 12 hours. See carton for dosing instructions. Use only as directed.
• Adults and children 12 years of age and over: Take 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
• Children 6 to under 12 years of age: Take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
• Children under 6 years of age: Do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Allegra side effects

Like all medicines, Allegra (Fexofenadine) can cause side effects, although not everyone gets them.

Common side effects

Common side effects of Allegra (Fexofenadine) happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• feeling sick
• vomiting
• feeling sleepy
• headache
• dry mouth
• feeling dizzy

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

Gastrointestinal

• Very common (10% or more): Vomiting (up to 12%)
• Common (1% to 10%): Nausea, diarrhea, stomach discomfort

Nervous system

• Very common (10% or more): Headache (up to 10.3%)
• Common (1% to 10%): Drowsiness, dizziness, somnolence

Other side effects

• Common (1% to 10%): Otitis media, pyrexia, fatigue, extremity pain

Respiratory

• Common (1% to 10%): Cough, upper respiratory tract infection, rhinorrhea
• Frequency not reported: Dyspnea

Musculoskeletal

• Common (1% to 10%): Back pain

Genitourinary

• Common (1% to 10%): Dysmenorrhea

Psychiatric

• Frequency not reported: Insomnia, nervousness, nightmares, sleep disorders or paroniria/excessive dreaming

Cardiovascular

• Frequency not reported: Palpitations, tachycardia, chest tightness

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions, angioedema, systemic anaphylaxis

Dermatologic

• Frequency not reported: Rash, pruritus, flushing

Less common side effects

• back pain
• body aches or pain
• chills
• coughing
• diarrhea
• difficulty with moving
• dizziness
• ear congestion
• earache
• fever
• headache
• joint pain
• loss of voice
• muscle aching or cramping
• muscle pains or stiffness
• nasal congestion
• nausea
• pain in arms or legs
• pain or tenderness around eyes or cheekbones
• painful menstrual bleeding
• redness or swelling in ear
• ringing or buzzing in ears
• runny or stuffy nose
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stomach upset
• swollen joints
• unusual feeling of tiredness or weakness
• viral infection (such as cold and flu)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Rare side effects

• Nervousness
• Rash
• Sleeplessness
• Terrifying dreams
• Trouble sleeping
• Chest tightness
• Feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Shortness of breath, difficult or labored breathing

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you have any of the side effects listed above.

Serious side effects

It’s rare to have a serious side effect with Allegra (Fexofenadine).

• Tell your doctor straight away if you have a fast or irregular heartbeat.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Allegra (Fexofenadine).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Allegra (Fexofenadine). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – stick to simple meals and don’t eat rich or spicy food
• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor
• headache – take an everyday painkiller like paracetamol or ibuprofen
• dry mouth – chew sugar-free gum or suck sugar-free sweets
• feeling dizzy – lie down until the dizziness passes, then get up slowly. Move slowly and carefully. Avoid coffee, cigarettes, alcohol and recreational drugs. If the dizziness doesn’t get better within a couple of days, speak to your pharmacist or doctor.

Human Toxicity Reports

Safety and efficacy of fexofenadine hydrochloride have not been established in children younger than 6 years of age ⁶.

In clinical trials, dysmenorrhea occurred in 1.5% of patients receivingoral fexofenadine 60 mg twice daily, compared to 0.3% in patients receiving placebo ¹⁰.

In controlled clinical studies in patients 12 years of age and older with allergic rhinitis receiving oral fexofenadine hydrochloride dosages of 60 mg twice daily or placebo, drowsiness or fatigue occurred in 1.3% of patients, compared with 0.9% of those receiving placebo ¹¹. In these studies in patients receiving fexofenadine hydrochloride dosages of 180 mg once daily (as conventional tablets) or placebo, headache was reported in 10.6 or 7.5% of patients, respectively. In controlled studies in children 6-11 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride dosages of 30 mg twice daily or placebo, headache was reported in 7.2 or 6.6% of patients, respectively, while pain was reported in 2.4 or 0.4% of patients, respectively ¹¹.

During controlled clinical studies, nausea and dyspepsia were reported in 1.6 and 1.3%, respectively, of patients receiving oral fexofenadine hydrochloride dosages of 60 mg twice daily versus 1.5 and 0.6%, respectively, of those receiving placebo ¹¹.

Rash, urticaria, pruritus, and hypersensitivity reactions including angioedema, chest tightness, dyspnea, flushing, or anaphylaxis have been reported rarely in patients receiving fexofenadine hydrochloride ⁶.

In controlled studies in adults and children 12 years and older with chronic idiopathic urticaria receiving fexofenadine hydrochloride dosages of 60 mg twice daily or placebo, both back pain and sinusitis were reported in 2.2 or 1.1% of patients, respectively ⁶.

Clinical data from over 2000 patients indicate that fexofenadine hydrochloride lacks the cardiotoxic potential of its parent drug terfenadine ¹¹. In 714 patients with seasonal allergic rhinitis, fexofenadine hydrochloride dosages of 60-240 mg twice daily were not associated with statistically significant mean increases in the QT interval corrected for rate (QTc) in controlled clinical studies. In addition, in 231 healthy individuals, fexofenadine hydrochloride dosages of 240 mg given once daily for 1 year also were not associated with statistically significant increases in the mean QTc. Even at dosages exceeding these (e.g., up to 400 mg twice daily for 6 days in 40 patients, up to 690 mg twice daily for about 1 month in 32 patients, up to 800 mg given in a single dose in 87 patients), statistically significant mean increases in the QTc or other ECG abnormalities have not been reported in healthy adults or patients with seasonal allergic rhinitis ¹¹.

Viral infection (eg, cold, influenza) or dysmenorrhea was reported in 2.5 or 1.5% of patients 12 years of age and older receiving fexofenadine hydrochloride in dosages of 60 mg twice daily, respectively. In controlled clinical studies in adults and children 12 years of age and older receiving fexofenadine hydrochloride dosages of 180 mg once daily or placebo, upper respiratory tract infection was reported in 3.2 or 3.1% of patients, respectively, while back pain was reported in 2.8 or 1.4% of patients, respectively ⁶.

In controlled studies in children 6-11 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride 30 mg twice daily, upper respiratory tract infection, coughing, accidental injury, fever, and otitis media occurred in 4.3, 3.8, 2.9, 2.4, and 2.4% of children, respectively, while these adverse effects were reported in 1.7, 1.3, 1.3, 0.9, and 0%, respectively, in those receiving placebo ⁶.

To gain insight into possible mechanisms of and predisposing factors for torsades de pointes during terfenadine therapy, spontaneous reports in the US Food and Drug Administration’s Spontaneous Reporting System database were examined ¹². Based on the characteristics of the cases, in vitro cardiac electrophysiologic studies were conducted to test the hypothesis that terfenadine, and not its major metabolite, has actions similar to those of quinidine and is responsible for this form of cardiac toxicity. Spontaneous reports from the general medical community. As of April 1, 1992, 25 cases of torsades de pointes had been reported to the Food and Drug Administration’s Spontaneous Reporting System. Predisposing factors in these cases indicated that the parent drug Terfenadine, but not its metabolite Fexofenadine, may have actions similar those of quinidine that are responsible for inducing arrhythmia ¹². In vitro studies found that terfenadine is equipotent to quinidine as a blocker of the delayed rectifier potassium current in isolated feline myocytes. The metabolite, terfenadine carboxylate, did not inhibit this potassium current even at concentrations 30 times higher than the concentration of terfenadine producing a half-maximal effect. Since blockade of the potassium channel did not occur with the major metabolite of terfenadine, episodes of torsades de pointes are most likely the result of a quinidine-like action of the parent drug and of factors that impair the normally rapid metabolism of terfenadine. Dosage restriction and awareness of the clinical conditions and drug interactions capable of inhibiting the metabolism of terfenadine are essential for prevention of this serious reaction ¹². In controlled trials with approximately 6,000 persons, no case of fexofenadine-associated torsades de pointes was observed. The frequency and magnitude of QTc outliers were similar between fexofenadine HCl and placebo in all studies. Based on a large clinical database, the authors conclude that fexofenadine HCl has no significant effect on QTc, even at doses > 10-fold higher than that is efficacious for seasonal allergic rhinitis ¹³.

Allegra overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Little information is available regarding toxicity. Clinical effects are anticipated to be an extension of adverse effects reported with therapeutic use. Dizziness, drowsiness, and dry mouth have been reported with fexofenadine overdose.

Symptoms of Allegra overdose may include:

• dizziness
• drowsiness
• dry mouth

1. Gilboa SM, et al. 2009. National Birth Defects Prevention Study: Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 85(2):137-150.[↩]
2. Diav-Citrin O, et al. 2003. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study. J Allergy Clin Immunol 111(6):1239-1243.[↩]
3. Kallen B. 2002. Use of antihistamine drugs in early pregnancy and delivery outcome. J Matern Fetal Neonatal Med 11:146-152.[↩]
4. Schatz M, Petitti D. 1997. Antihistamines and pregnancy. Ann Allergy Asthma Immunol 78:157-159.[↩][↩]
5. Loebstein R, et al. 2000. Pregnancy outcome after gestational exposure to terfenadine: A multicenter, prospective controlled study. Immunology and Allergy Clinics of North America 20(4):807-30.[↩]
6. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 34[↩][↩][↩][↩][↩][↩][↩]
7. Lucas BD Jr, et al: 1995. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. Apr;57(4):398-402.[↩]
8. Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 168:1393-9.[↩]
9. Handing KB, Shabalin IG, Szlachta K, Majorek KA, Minor W. Crystal structure of equine serum albumin in complex with cetirizine reveals a novel drug-binding site. Molecular immunology. 2016;71:143-151. doi:10.1016/j.molimm.2016.02.003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800003/[↩][↩]
10. Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 2859[↩]
11. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 33[↩][↩][↩][↩][↩]
12. Woosley RL et al; JAMA 269 (12): 1532-6, 1993 https://jamanetwork.com/journals/jama/article-abstract/404647[↩][↩][↩]
13. Pratt CM et al; Am J Cardiol 83 (10): 1451-4; 1999 https://www.ncbi.nlm.nih.gov/pubmed/10335761[↩]

What is Excedrin

Excedrin is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Interestingly, the products sold as Excedrin Migraine, Excedrin Menstrual and Excedrin Tension Headache contain identical active ingredients even though advertised for different conditions!

Excedrin ingredients

The active ingredients in Excedrin are Acetaminophen + Aspirin + Caffeine.

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Aspirin

Aspirin is also known as acetylsalicylic acid in a class of drug called nonsteroidal anti-inflammatory drugs (NSAIDs) that is similar to non-steroidal inflammatory (NSAIDs) like Ibuprofen (Motrin or Advil) and naproxen (Aleve). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation.

Aspirin can prevent the formation of blood clots which can make it useful in treating or preventing some conditions like heart attacks and strokes. The dosage for aspirin can range from 50 to 6000 milligrams (mg) per day depending on the condition being treated, and aspirin may be used in combination with other medications.

Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina).

Aspirin is a common medicine that has a number of uses, from relieving pain to reducing the risk of serious problems such as heart attacks and strokes.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin can be used to treat:

• Mild to moderate pain
• Fever
• Swollen, red and tender body tissues
• Rheumatoid arthritis
• Rheumatic fever ¹

It is also used in the prevention of blood clots, heart attacks, strokes and bowel cancer ¹.

Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Uses for aspirin

At high doses – usually 300mg – aspirin can relieve pain, reduce a high temperature (fever) and reduce swelling.

Aspirin is often used for short-term relief from:

• headaches and migraines
• toothache
• period pains
• general aches and pains
• colds and flu

Long-term treatment with low doses of aspirin – usually 75mg – has an antiplatelet effect, which means it makes the blood less sticky and can stop blood clots developing.

A doctor may recommend low doses of aspirin (75mg) if you have or have had:

• a heart attack or angina
• a stroke or transient ischemic attack (TIA)
• peripheral arterial disease
• coronary artery bypass surgery or another operation on your heart or blood vessels

Aspirin may also be prescribed for children after heart surgery or to treat Kawasaki disease. But it shouldn’t be given to anyone under 16 years old without medical supervision.

Who can and can’t take Aspirin

Most people can take aspirin safely. But you should get advice from a pharmacist or doctor before taking it if you:

• have had an allergic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, in the past
• have asthma
• have had stomach ulcers in the past
• have severe liver or kidney problems
• have hemophilia or another bleeding disorder
• have uncontrolled high blood pressure
• are looking for medication for a child under 16 – medication containing aspirin shouldn’t be given to children under 16
• are over 65 years of age
• are pregnant, breastfeeding or trying to get pregnant
• are taking other medications

You may still be able to take aspirin in these cases, but you should only do so if advised that it’s safe by a healthcare professional.

If you can’t take aspirin, a different medicine, such as paracetamol (for pain) or clopidogrel (to prevent blood clots), may be recommended instead.

Before taking aspirin

• tell your doctor and pharmacist if you are allergic to aspirin, other medications for pain or fever, tartrazine dye, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants (‘blood thinners’) such as warfarin (Coumadin) and heparin; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics (‘water pills’); medications for diabetes or arthritis; medications for gout such as probenecid and sulfinpyrazone (Anturane); methotrexate (Trexall); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• if you are taking aspirin on a regular basis to prevent heart attack or stroke, do not take ibuprofen (Advil, Motrin) to treat pain or fever without talking to your doctor. Your doctor will probably tell you to allow some time to pass between taking your daily dose of aspirin and taking a dose of ibuprofen.
  tell your doctor if you have or have ever had asthma, frequent stuffed or runny nose, or nasal polyps (growths on the linings of the nose). If you have these conditions, there is a risk that you will have an allergic reaction to aspirin. Your doctor may tell you that you should not take aspirin.
• tell your doctor if you often have heartburn, upset stomach, or stomach pain and if you have or have ever had ulcers, anemia, bleeding problems such as hemophilia, or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking aspirin, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin.
• if you drink three or more alcoholic drinks every day, ask your doctor if you should take aspirin or other medications for pain and fever.

How to take aspirin

Your pharmacist or doctor can tell you how often to take your aspirin and how much you should take. You can also check the recommendations in the leaflet that comes with your medicine.

Generally speaking:

• high-dose aspirin (to relieve pain) can be taken three or four times a day, with at least four hours between each dose, until your symptoms improve
• low-dose aspirin (to prevent blood clots) is taken once a day, usually for the rest of your life

Some medicine leaflets advise taking aspirin with water, while others may recommend taking it before or after food.

Follow the instructions in the leaflet or label that comes with your medicine. Ask your pharmacist if you’re not sure.

Aspirin interactions with other medicines, food and alcohol

Aspirin can potentially interact with other medications, including some complementary and herbal medicines, which could alter their effects or increase your risk of side effects.

Medicines that can interact with aspirin include:

• NSAIDs – such as ibuprofen or naproxen
• steroid medication – such as prednisolone
• anticoagulant medicines – such as warfarin or heparin
• SSRI antidepressants – such as citalopram, fluoxetine or paroxetine
• some medications used to treat high blood pressure – such as ACE inhibitors or diuretics
• some medicines used to treat epilepsy – such as phenytoin
• other medicines containing aspirin – including cold and flu remedies where aspirin is one of the ingredients

Taking aspirin with warfarin (anticoagulant medicine or blood thinner) or some blood pressure medicines may increase the risk of bleeding.

This is not a complete list. If you want to check whether a medicine is safe to take with aspirin, ask your doctor or pharmacist, or read the leaflet that comes with the medicine.

There are no known interactions between aspirin and food.

The risk of bleeding in the stomach may be higher if you drink alcohol while taking aspirin, so you may want to consider reducing how much you drink or avoiding alcohol completely.

Side effects of aspirin

Like all medications, there’s a risk of side effects from aspirin.

The most common side effects are:

• Indigestion and stomach aches – taking your medicine with food may help reduce this risk
• Bleeding or bruising more easily than normal

Other side effects of aspirin:

• Dizziness, ringing in the ears, blurred vision
• Drowsiness, fatigue, depression
• Thirst, sweating, fluid retention, swollen ankles
• Abdominal discomfort or bloating
• Nausea, heartburn, diarrhea, constipation

Uncommon and rare side effects include:

• hives – a raised, itchy rash
• tinnitus – hearing sounds that come from inside your body
• breathing difficulties or an asthma attack
• an allergic reaction – this can cause breathing problems, swelling of the mouth, lips or throat, and a sudden rash
• bleeding in the stomach – this can cause dark, tar-like stools or vomiting blood
• bleeding in the brain – this can cause a sudden, severe headache, vision problems and stroke symptoms, such as slurred speech and weakness on one side of the body

Long-term effects of taking aspirin:

Regular use of aspirin may eventually cause the following effects. It’s best to discuss the side effects of long term use with a medical practitioner.

• Anemia (low red blood cell count)
• Easy bruising and abnormal bleeding
• Inflamed stomach lining, stomach bleeding and peptic ulcers
• Vomiting blood that may look like coffee grounds and bowel motions that look like black tar
• An allergic-type reaction, wheezy breathing and a tightness in the chest in adults, hives in children, and in some rare cases swelling of the face, lips, tongue or around the eyes
• Reduced kidney and liver function

Speak to your doctor if you experience any concerning or troublesome side effects while taking aspirin.

Call your emergency number for an ambulance or go to your nearest accident and emergency (A&E) department if you think you’re having a severe allergic reaction, or you have symptoms of bleeding in your stomach or brain.

Aspirin Overdose

If the dose is too high, you might overdose. If you have any of these symptoms, call an ambulance straight away by dialing your local emergency number.

• Headaches
• Confusion
• Fever
• Deafness
• Vomiting
• Rapid and shallow breathing
• Seizures
• Stop breathing, coma and death
• Burning pain in the throat or stomach
• Decreased urination
• Restlessness
• Irritability
• Talking a lot and saying things that do not make sense
• Fear or nervousness
• Dizziness
• Double vision
• Uncontrollable shaking of a part of the body
• Abnormally excited mood
• Hallucination (seeing things or hearing voices that are not there)
• Drowsiness
• Loss of consciousness for a period of time

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Excedrin = 130mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ³

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ⁴.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁵

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁶

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁷

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁵.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁸.

How much caffeine in Excedrin

• Excedrin Migraine: Acetaminophen 250mg + Caffeine 65 mg + Aspirin 250mg
• Excedrin Tension Headache: Acetaminophen 500mg + Caffeine 65 mg
• Excedrin Extra Strength: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Excedrin Important Information

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

Do not take more Excedrin than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Excedrin and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Excedrin Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity ⁹.

Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women ¹⁰, ¹¹. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women ¹⁰. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women ¹².

One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women ¹³. That study also suggested that acetaminophen does not affect thromboxane production.

The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs ¹⁴.

Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery ¹⁵, ¹⁶, ¹⁷. Prolonged gestation and labor have been reported due to aspirin’s inhibition of prostaglandin.

A study ¹⁸ of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy–CLASP) did “not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR.” In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

Another study ¹⁹ of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that “low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.”

High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported ¹⁹, ¹⁵. However, a case control study of aspirin use in the first trimester concluded that aspirin “does not increase the risk of congenital heart defects in relation to that of other structural malformations”.

In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Aspirin has been assigned to pregnancy category C by the FDA. However, aspirin is considered to be in pregnancy category D by the FDA if full dose aspirin is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects.

Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations.

Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. During the first two trimesters of pregnancy, the combination of acetaminophen, aspirin, and caffeine should only be given during pregnancy when clearly needed and when benefit outweighs risk. Because of the aspirin component of this combination drug, during the last trimester of pregnancy, this combination product is only recommended for use when there are no alternatives and benefits outweigh risk.

Excedrin Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose ²⁰.

Aspirin is excreted into human milk in small amounts ²¹, ²². Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics ²³ characterizes aspirin as a drug that has been “associated with significant effects on some nursing infants and should be given to nursing mothers with caution.”

Acetaminophen is excreted into human milk in small concentrations ²¹. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics.

Caffeine is excreted into human milk in small amounts ²⁴. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

Before taking Excedrin

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin.

Ask a doctor or pharmacist if it is safe for you to take Excedrin if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• asthma or seasonal allergies;
• fever with a stiff neck;
• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;
• a bleeding or blood clotting disorder such as hemophilia;
• kidney disease; or
• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;
• a headache that causes vomiting;
• what feels like the worst headache you’ve ever had;
• a headache that seems different from your usual headaches;
• a headache every day;
• a headache after coughing, bending, exercising, or head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin.

How should I take Excedrin?

Use Excedrin exactly as directed on the label, or as it has been prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Take Excedrin with food or milk if it makes your stomach upset.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin.

If you need surgery, tell the surgeon ahead of time that you are using Excedrin. You may need to stop using the medicine for a short time.

Store Excedrin at room temperature away from moisture and heat.

What should I avoid?

Avoid drinking alcohol while you are taking Excedrin. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, menstrual symptom, or fever medication. Acetaminophen (paracetamol) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Aspirin and caffeine are also contained in many combination medicines. Check the label to see if a medicine contains acetaminophen (paracetamol), aspirin, or caffeine.

Avoid taking another NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking Excedrin. They can add to the side effects of the caffeine in the medication.

What happens if I miss a dose?

Since Excedrin is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Excedrin dosage

Excedrin (Acetaminophen + Aspirin + Caffeine) Dosage

• Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Usual Adult Dose for Analgesic/Antipyretic

Up to a total of 650 of acetaminophen and aspirin combined every 4-6 hours as needed.

Usual Adult Dose for Migraine

500 mg acetaminophen, 500 mg aspirin, and 130 mg of caffeine in combination per day as needed.

Maximum duration of migraine therapy: 48 hours

Renal Dose Adjustments

Detailed information concerning the pharmacokinetic disposition of aspirin in patients with renal dysfunction is not available. Aspirin should be used with caution in chronic renal insufficiency, since it may cause a transient decrease in renal function. The use of aspirin in patients with severe renal impairment (CrCl less than 10 mL/minute) is not recommended due to the potential for increased risk of salicylate toxicity.

Liver Dose Adjustments

Use acetaminophen with caution in patients with liver disease. Chronic use of acetaminophen is not recommended in patients with liver disease.

The use of aspirin in patients with severe hepatic impairment is not recommended due to the potential for increased risk of clinically significant bleeding and other adverse effects.

Kidney Dialysis

Detailed information concerning the removal of aspirin by hemodialysis is not available. Some investigators have suggested that aspirin and/or salicylate may be removed by hemodialysis and that aspirin dosing should follow dialysis sessions.

Excedrin Tension Headache

Active ingredients: Acetaminophen 500 mg + Caffeine 65 mg

Inactive Ingredients: Carnauba wax, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate acid, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, stearic acid, talc, titanium dioxide

Excedrin Tension Headache uses:

• Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular Aches

Excedrin Tension Headache Directions of Use:

• Do not use more than directed
• Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
• Children under 12 years: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Tension Headache Warnings

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Ask a doctor before use if:

• you have liver disease
• you are pregnant or breastfeeding
• you are taking taking the blood thinning drug warfarin.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do NOT use

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• any new symptoms occur
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

Excedrin Extra Strength

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin Extra Strength uses:

• Temporarily relieves minor aches and pains due to:
  • Headache
  • A Cold
  • Arthritis
  • Muscular Aches
  • Toothache
  • Premenstrual and Menstrual Cramps

Excedrin Extra Strength Directions of Use:

• Do not use more than directed
• Drink a full glass of water with each dose
• Adults and children 12 years and over: Take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
• Children under 12 years: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Extra Strength Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition

Ask a doctor before use if:

• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms occur

These could be signs of a serious condition.

Excedrin Migraine

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin Migraine uses:

• Treats Migraines
  

Excedrin Migraine Directions of Use:

• Do not use more than directed. If symptoms persist or worsen, ask your doctor
• Drink a full glass of water with each dose
• Adults: Take 2 caplets with a glass of water. Do not take more than 2 caplets in 24 hours, unless directed by a doctor.
• Under 18 years of age: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Migraine Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Ask a doctor before use if:

• you have never had migraines diagnosed by a health professional
• you have a headache that is different from your usual migraines
• you have the worst headache of your life
• you have fever and stiff neck
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
• you experienced your first headache after the age of 50
• you have daily headaches
• you have a migraine so severe as to require bed rest
• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have vomiting with your migraine headache

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 2 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• your migraine is not relieved or worsens after first dose
• ringing in the ears or loss of hearing occurs
• any new or unexpected symptoms occur

These could be signs of a serious condition.

Excedrin side effects

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate premenstrual syndrome (PMS).

In general, many side effects noted with aspirin use are dose-related.

Common Excedrin side effects may include:

• upset stomach, heartburn;
• depressed mood, feeling anxious or restless; or
• sleep problems (insomnia).

Excedrin serious side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Excedrin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Excedrin and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using Excedrin and call your doctor at once if you have:

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;
• symptoms of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• high potassium–slow heart rate, weak pulse, muscle weakness, tingly feeling; or
• liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling confused.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Ringing in ears.
• Hearing loss.
• Very bad headache or if headache is not better after the first dose.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad stomach ulcers or bleeding can happen with this drug. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking this drug with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

Other side effects of Exedrin

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hepatic side effects including hepatotoxicity and hepatitis have been reported.

In alcoholic patients, severe and sometimes fatal dose dependent hepatitis has been reported with acetaminophen use. Hepatotoxicity has been increased during fasting.

Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.

Gastrointestinal

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin containing rectal suppositories. One case controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

Gastrointestinal side effects have been common and have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose.

Renal

The mechanism of an aspirin induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.

Acetaminophen: Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A case control study of patients with end stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end stage renal disease particularly in patients taking more than two pills per day.

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects have been rare with acetaminophen use and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen related hepatotoxicity.

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity reactions such as anaphylaxis and fixed drug eruptions have rarely been reported in association with acetaminophen use.

The mechanism of aspirin induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.

Rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects from the use of aspirin including Stevens-Johnson syndrome and a lichenoid eruption have been reported rarely.

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP). Erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported.

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.

A case of acetaminophen induced eosinophilic pneumonia has been reported.

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.

Cardiovascular side effects of aspirin have been reported rarely and have included salicylate induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.

Several cases of hypotension have been reported following the administration of acetaminophen.

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has also been reported in a patient on hemodialysis.

Nervous system

Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.

Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.

Endocrine

Endocrine side effects of aspirin use have included hypoglycemia and hyperglycemia.

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.

Oncologic

Oncologic side effects have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found this beneficial effect.

Other side effects

Other side effect have also been reported. In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.

Reye’s syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye’s syndrome has also been reported even more rarely in adults.

Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.

Reye’s syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Excedrin overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

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