Orajel

by Health Jade Team on May 30, 2018

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.

Discontinuation of Teething Products

Public announcement from the manufacturer of Orajel™ ²

“The safety of our consumers and their children is our highest priority. Based on the May 23, 2018 communication from the U.S. Food and Drug Administration regarding over-the-counter (OTC) teething products containing benzocaine, we are discontinuing the distribution and sale of Orajel™ teething products containing benzocaine. Orajel™ teething products containing benzocaine and labeling have complied with applicable and evolving FDA requirements since we acquired the brand in 2008. 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”.

“In addition, we also are revising the Drug Facts Label on all over-the-counter oral health care products that contain benzocaine with an intended use other than teething to emphasize that these products should not be used for teething pain or in children under 2 years of age. In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine”.

U.S. Food and Drug Administration (FDA) Warnings on Oral OTC Benzocaine Products

U.S. Food and Drug Administration (FDA) is warning parents and caregivers that benzocaine products should not be used to treat teething pain in infants or children ³

Safety Announcement

The U.S. Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. The U.S. Food and Drug Administration (FDA) are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.

Consumers using benzocaine products to treat mouth pain should seek medical attention immediately for signs and symptoms of methemoglobinemia.

Signs and symptoms of methemoglobinemia include:

pale, gray or blue-colored skin, lips, and nail beds;
shortness of breath;
fatigue;
confusion;
headache;
lightheadedness; and
fast heart rate.

Signs and symptoms of methemoglobinemia may appear within minutes to one to two hours after using benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after prior uses.

Benzocaine is a local anesthetic contained in some over-the-counter (OTC) products for the temporary relief of pain due to minor irritation, soreness, or injury of the mouth and throat. Benzocaine products are marketed as gels, sprays, ointments, solutions, and lozenges under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine, and Topex, as well as store brands and generics. Prescription local anesthetics include articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine, and tetracaine.

The U.S. Food and Drug Administration (FDA) have been closely monitoring the risk of methemoglobinemia with the use of over-the-counter (OTC) and prescription local anesthetics and previously communicated about this risk in 2014, 2011, and 2006. The U.S. Food and Drug Administration (FDA) estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA or published in the medical literature since 1971. There are likely additional cases about which the FDA are unaware.

As part of our continued monitoring of this safety risk, the U.S. Food and Drug Administration (FDA) recently evaluated 119 cases of benzocaine-associated methemoglobinemia reported to FDA and identified in the medical literature in the 8½ years between February 2009 and October 2017. The U.S. Food and Drug Administration (FDA) have continued to receive cases even after their 2014 communication. Most of the 119 cases were serious and required treatment. Twenty-two cases occurred in patients younger than 18 years, and 11 of these were in children younger than 2 years. Four patients died among the 119 patients, including one infant. The U.S. Food and Drug Administration (FDA) also conducted a study comparing the relative ability of the two local anesthetics benzocaine and lidocaine to make methemoglobin. The study showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model.

The U.S. Food and Drug Administration (FDA) urge patients, consumers, and health care professionals to report side effects involving benzocaine, prescription local anesthetics, or other medicines to the FDA MedWatch program. 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).

Due to the significant safety risk of methemoglobinemia, the U.S. Food and Drug Administration (FDA) have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, the FDA will take action to remove these products from the market. The U.S. Food and Drug Administration (FDA) have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products:

Adding a warning about methemoglobinemia;
Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

The U.S. Food and Drug Administration (FDA) continue to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. The U.S. Food and Drug Administration (FDA) will notify the public about any updates. In addition to their recent actions regarding OTC benzocaine products, the FDA are also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics.

Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain ⁴:

Gently rub or massage the child’s gums with one of your fingers.
Use a firm rubber teething ring.
If these remedies don’t provide relief, contact your health care professional for advice on other treatments.

Topical pain relievers and medications that are rubbed on the gums are not useful because they wash out of a baby’s mouth within minutes. FDA has previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children. FDA confirms elevated levels of belladonna in certain homeopathic teething products ⁵.

Alternative treatments for adults who experience mouth pain may include dilute salt water mouth rinse and OTC pain relief medications. Adults should follow the American Dental Association’s recommendations for mouth sores and spots ⁶:

Schedule regular oral health checkups
Keep a diary of what you eat and drink
Keep a list of oral hygiene products you have been using
Avoid all tobacco products
If you drink alcoholic beverages, do so in moderation
See your dentist if you notice any change in your mouth

Health care professionals should warn patients of the possibility of methemoglobinemia and advise them of the signs and symptoms when recommending or prescribing local anesthetic products.

Some patients are at greater risk for complications related to methemoglobinemia. This includes those with breathing problems such as asthma, bronchitis, or emphysema; heart disease, and the elderly. Health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia. These include monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue.

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.

References

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/
http://www.orajel.com/
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
Teething: 4 to 7 Months. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx
FDA confirms elevated levels of belladonna in certain homeopathic teething products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm
https://www.ada.org/~/media/ADA/Publications/Files/ADA_PatientSmart_Mouth_Sores.pdf?la=en
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.
Methemoglobinemia. https://medlineplus.gov/ency/article/000562.htm

Drugs OTC

Afrin

by Health Jade Team on May 29, 2018

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.

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.

References

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824
Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985
Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990
Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604
Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532
Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333
Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470
Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069
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/
Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016
Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795
Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983

Drugs OTC

Zicam

by Health Jade Team on May 29, 2018

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

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

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.

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.

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

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

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.

References

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824
Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985
Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990
Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604
Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532
Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333
Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470
Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069
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/
Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016
Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795
Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983

Drugs OTC

Dulcolax

by Health Jade Team on May 29, 2018

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:

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.
Remove the wrapper.
If you were told to use half of the suppository, cut it lengthwise with a clean, sharp knife or blade.
Lie down on your left side and raise your right knee to your chest.
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.
Hold it in place for as long as possible.
Wash your hands thoroughly.

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

Shake the enema bottle well.
Remove the protective shield from the tip.
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.
Gently insert the enema bottle into the rectum with the tip pointing toward the navel.
Squeeze the bottle gently until the bottle is nearly empty.
Remove the enema bottle from the rectum. Hold the enema contents in place as long as possible, for up to 10 minutes.
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.

References

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
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
Cowl, C.T. Physician’s Handbook 10th edition. Lippincott Williams & Wilkins, Philadelphia, PA. 2003, p. 209
Bisacodyl https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~38hWnu: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
American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 813
Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 1363
Wu WJ et al; J Formos Med Assoc 92 (11): 1004-6; 1993 https://www.ncbi.nlm.nih.gov/pubmed/7910057
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

Drugs OTC

Midol

by Health Jade Team on May 29, 2018

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)

Product	Average caffeine content (mg/100 ml)
Red Bull®	32.0
Mountain Dew®	15.0
Coca Cola®	9.7*
Diet Coke®	9.7*
Coke Zero®	9.6*
Brewed black tea	22.5
Brewed green tea	12.1
Coffee, cappuccino	101.9
Coffee, flat white	86.9
Coffee, long black	74.7
Coffee, from ground coffee beans, espresso style	194.0
Chocolate, milk with added milk solids	20.0
Chocolate, dark, high cocoa solids	59.0

[Source ¹]

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.

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

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.

References

Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
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/
Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
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/
Pyrilamine maleate. https://pubchem.ncbi.nlm.nih.gov/compound/pyrilamine_maleate

Drugs OTC

Colace

by Health Jade Team on May 29, 2018

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

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.

References

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
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
Danthron. https://pubchem.ncbi.nlm.nih.gov/compound/danthron

OTC

Allegra

by Health Jade Team on May 29, 2018

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)

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

References

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.
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.
Kallen B. 2002. Use of antihistamine drugs in early pregnancy and delivery outcome. J Matern Fetal Neonatal Med 11:146-152.
Schatz M, Petitti D. 1997. Antihistamines and pregnancy. Ann Allergy Asthma Immunol 78:157-159.
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.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 34
Lucas BD Jr, et al: 1995. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. Apr;57(4):398-402.
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.
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/
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 2859
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 33
Woosley RL et al; JAMA 269 (12): 1532-6, 1993 https://jamanetwork.com/journals/jama/article-abstract/404647
Pratt CM et al; Am J Cardiol 83 (10): 1451-4; 1999 https://www.ncbi.nlm.nih.gov/pubmed/10335761

Drugs OTC

Excedrin

by Health Jade Team on May 28, 2018

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 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

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 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)

Product	Average caffeine content (mg/100 ml)
Red Bull®	32.0
Mountain Dew®	15.0
Coca Cola®	9.7*
Diet Coke®	9.7*
Coke Zero®	9.6*
Brewed black tea	22.5
Brewed green tea	12.1
Coffee, cappuccino	101.9
Coffee, flat white	86.9
Coffee, long black	74.7
Coffee, from ground coffee beans, espresso style	194.0
Chocolate, milk with added milk solids	20.0
Chocolate, dark, high cocoa solids	59.0

[Source ²]

Effects of caffeine

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?

How does caffeine affect you and your baby during pregnancy?

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.

Can caffeine cause or make it more likely to have a 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.

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?

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

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

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, 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.

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.

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

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)]

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.

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

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

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).

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

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

References

Upfal J. (2006) The Australian Drug Guide (7th Ed.) Melbourne: Black Inc.
Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
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/
Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
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/
Byer AJ, Traylor TR, Semmer JR “Acetaminophen overdose in the third trimester of pregnancy.” JAMA 247 (1982): 3114-5
Rayburn W, Shukla U, Stetson P, Piehl E “Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women.” Am J Obstet Gynecol 155 (1986): 1353-6
Galinsky RE, Levy G “Absorption and metabolism of acetaminophen shortly before parturition.” Drug Intell Clin Pharm 18 (1984): 977-9
Beaulac-Baillargeon L, Rocheleau S “Paracetamol pharmacokinetics during the first trimester of human pregnancy.” Eur J Clin Pharmacol 46 (1994): 451-4
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
Briggs GG, Freeman RK, Yaffe SJ.. “Drugs in Pregnancy and Lactation. 5th ed.” Baltimore, MD: Williams & Wilkins;1998
Rudolph AM “Effects of aspirin and acetaminophen in pregnancy and in the newborn.” Arch Intern Med 141 (1981): 358-63
Karlowicz MG, White LE “Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion.” Clin Pediatr (Phila) 32 (1993): 740-3
Schoenfeld A, Bar Y, Merlob P, Ovadia Y “NSAIDs: maternal and fetal considerations.” Am J Reprod Immunol 28 (1992): 141-7
“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
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
Committee on Drugs, 1992 to 1993 “The transfer of drugs and other chemicals into human milk.” Pediatrics 93 (1994): 137-50
Matheson I, Lunde PK, Notarianni L “Infant rash caused by paracetamol in breast milk.” Pediatrics 76 (1985): 651-2
Erickson SH, Oppenheim GL “Aspirin in breast milk.” J Fam Pract 8 (1979): 189-90
Roberts RJ, Blumer JL, Gorman RL, et al “American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk.” Pediatrics 84 (1989): 924-36
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

Drugs OTC

Pepto bismol

by Health Jade Team on May 27, 2018

What is Pepto Bismol

Pepto-Bismol is an antacid and anti-diarrhea medication. Pepto-Bismol is used to treat diarrhea in adults and children 12 years of age and older. Pepto-Bismol is also used to relieve the symptoms of an upset stomach, such as heartburn, indigestion, and nausea in adults and children 12 years of age and older. The active ingredient in Pepto-Bismol is bismuth subsalicylate.

Pepto-Bismol is available without a prescription. However, if you are taking Pepto Bismol (bismuth subsalicylate) medicine for diarrhea, check with your doctor:

if your symptoms do not improve within 2 days or if they become worse.
if you also have a high fever.

Pepto Bismol (bismuth subsalicylate) is available in the following dosage forms:

Suspension
Tablet
Tablet, Chewable

How does Pepto Bismol work?

Pepto Bismol (bismuth subsalicylate) is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Why does Pepto-Bismol sometimes darken the tongue/stool and how long does it last?

This discoloration is temporary and harmless. The active ingredient in Pepto-Bismol contains bismuth. When a small amount of bismuth combines with trace amounts of sulfur in your saliva and gastrointestinal tract, a black-colored substance (bismuth sulfide) is formed. This discoloration is temporary and harmless. It can last several days after you stop taking Pepto-Bismol. Individual bowel habits, your age (the intestinal tract slows down with age), and the amount of the product taken all help to determine how long Pepto-Bismol is in your system.

Can I give Pepto-Bismol to my child?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

For children 2 years and older, Children’s Pepto Antacid (contains Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet) can be used to relieve heartburn, acid indigestion, sour stomach, and upset stomach due to these symptoms. Note the difference between Children’s Pepto Antacid that contains Calcium Carbonate unlike the actual Pepto-Bismol that contains Bismuth subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements to aspirin.

I have been giving Pepto-Bismol to my child when he/she had an upset stomach – should I be concerned?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

Pepto Bismol contains both bismuth and subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements. Hepatic injury has been reported with chronic therapeutic use ¹. Salicylates have been linked with Reye’s syndrome in children. Hypoglycemia may develop, especially in children ¹.

The acute ingestion of less than 150 mg/kg or 6.5 g of aspirin equivalent, whichever is less, is not expected to cause significant toxicity.

In young children, the initial respiratory alkalosis from salicylate intoxication is transient, they often have a predominant metabolic acidosis (and in severe cases also respiratory alkalosis) on presentation.

What does the label say about Reye’s syndrome and Pepto-Bismol?

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use Pepto-Bismol. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements.

How should Pepto Bismol be used?

Pepto Bismol (bismuth subsalicylate) comes as a liquid, tablet, or chewable tablet to be taken by mouth, with or without food. Follow the directions on the package carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Pepto Bismol (bismuth subsalicylate) exactly as directed. Do not take more or less of it or take it more often than recommended by the manufacturer or your doctor.

Swallow the tablets whole; do not chew them.

Shake the liquid well before each use to mix the medication evenly.

If your symptoms get worse or if your diarrhea lasts longer than 48 hours, stop taking this medication and call your doctor.

Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with Pepto Bismol (bismuth subsalicylate).

Should I take Pepto-Bismol with or without food?

Pepto-Bismol can be taken either with or without food. Use as directed for relief of travelers’ diarrhea, diarrhea or upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness.

When can I take Pepto-Bismol?

Pepto-Bismol is an upset stomach reliever and antidiarrheal product. It can be taken any time you are experiencing diarrhea, travelers’ diarrhea or an upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness. When using the product follow the directions. Do not exceed 8 doses in a 24 hour period when using Pepto-Bismol.

Before taking Pepto Bismol – Precautions

In deciding to use Pepto Bismol, 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:

tell your doctor or pharmacist if you are allergic to salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan’s, others), and salsalate (Argesic, Disalcid, Salgesic); or any other medication.
check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking Pepto Bismol (bismuth subsalicylate) may lead to overdose. If you have any questions about this, check with your health care professional or pharmacist.
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 talk to your doctor or pharmacist about taking Pepto Bismol (bismuth subsalicylate) if you take: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); a daily aspirin; or medication for diabetes, arthritis or gout.
if you are taking tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin), take them at least 1 hour before or 3 hours after taking Pepto Bismol (bismuth subsalicylate).
ask your doctor before taking this medication if you have ever had an ulcer, bleeding problem, stools that are bloody or blackened, or kidney disease. Also ask your doctor before taking Pepto Bismol (bismuth subsalicylate) if you have a fever or mucus in your stool. If you will be giving Pepto Bismol (bismuth subsalicylate) to a child or teenager, tell the child’s doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child’s doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.
ask your doctor about taking this medication if you are pregnant or are breast-feeding.

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 take more than 8 doses in one day (24 hours).

Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.

Pepto Bismol (bismuth subsalicylate) can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken Pepto Bismol (bismuth subsalicylate).

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze.

Keep out of the reach of children. In case of Pepto Bismol overdose, call the Poison Control Helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

Do not keep outdated medicine or medicine no longer needed.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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.

Pediatric patients

This medicine should NOT be used in children younger than 12 years of age. The fluid loss caused by diarrhea may result in a severe condition. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

The bismuth in Pepto Bismol may cause severe constipation in children.

In addition, do not use Pepto Bismol (bismuth subsalicylate) to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child’s doctor immediately because this could be an early sign of Reye’s syndrome.

Geriatric patients

The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, the elderly may be more sensitive to the effects of salicylates. This may increase the chance of side effects during treatment. In addition, the bismuth in this medicine may cause severe constipation in the elderly.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to Pepto Bismol (bismuth subsalicylate) should be prescribed or you should stop breastfeeding while using Pepto Bismol (bismuth subsalicylate).

Diabetic patients

False urine sugar test results may occur if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.
Smaller doses or occasional use of Pepto Bismol (bismuth subsalicylate) usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
- you are not sure how much salicylate you are taking every day.
- you notice any change in your urine sugar test results.
- you have any other questions about this possible problem

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 Pepto Bismol (bismuth subsalicylate), 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.

Ask a doctor or pharmacist if it is safe for you to use Pepto Bismol (bismuth subsalicylate) if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin, Jantoven);
insulin or oral diabetes medications;
probenecid (Benemid);
an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or
other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

Using Pepto Bismol (bismuth subsalicylate) 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.

Aceclofenac
Acemetacin
Amtolmetin Guacil
Bromfenac
Bufexamac
Celecoxib
Clonixin
Dexibuprofen
Dexketoprofen
Diclofenac
Digoxin
Dipyrone
Droxicam
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Flurbiprofen
Ibuprofen
Indomethacin
Ketoprofen
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Morniflumate
Nabumetone
Naproxen
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Oxaprozin
Oxyphenbutazone
Parecoxib
Phenylbutazone
Piketoprofen
Piroxicam
Proglumetacin
Propyphenazone
Proquazone
Rofecoxib
Sulindac
Tenoxicam
Tiaprofenic Acid
Tolfenamic Acid
Tolmetin
Valdecoxib

Using Pepto Bismol (bismuth subsalicylate) 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.

Doxycycline
Probenecid
Sulfinpyrazone
Tamarind

Other Interactions

Pepto Bismol Pregnancy and Breastfeeding

Pepto Bismol Pregnancy Warnings

Safety has not been established during pregnancy; use is NOT recommended.

US FDA pregnancy category: Not assigned

Animal studies are inadequate. There are no controlled data in human pregnancy. Bismuth subsalicylate lacks reports of adverse fetal outcomes; however salicylates may cause congenital defects, increased perinatal mortality from ductus arteriosus in utero, intrauterine growth restriction, and salicylate intoxication.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Pepto Bismol Breastfeeding Warnings

Use is NOT recommended.

Excreted into human milk: Yes

The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios, rising from 0.03-0.08 at 3 hours to 0.34 at 12 hours ². Due to the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding. A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption.

Comments:

Bismuth is not expected to appear in high concentrations in breast milk due to poor systemic absorption.
Salicylates are excreted in breast milk.

What does Pepto Bismol do

Relieves travelers’ diarrhea, diarrhea and upset stomach due to over indulgence in food and drink including: heartburn, indigestion, nausea, gas, belching and fullness.

Pepto Bismol uses

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

For safe and effective use of Pepto Bismol (bismuth subsalicylate):

Follow your doctor’s instructions if Pepto Bismol (bismuth subsalicylate) was prescribed.
Follow the manufacturer’s package directions if you are treating yourself.

For patients using Pepto Bismol (bismuth subsalicylate) to treat diarrhea:

It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.
If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
- Decreased urination
- Dizziness and lightheadedness
- Dryness of mouth
- Increased thirst
- Wrinkled skin

If you are taking the oral suspension

Use the dose cup that is included to measure out the right amount of Pepto Bismol (bismuth subsalicylate). If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets

Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets

Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Pepto Bismol Dosing

Pepto Bismol (bismuth subsalicylate) is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Pepto Bismol (bismuth subsalicylate) should NOT be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

You should not use Pepto Bismol (bismuth subsalicylate) if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan’s Extra Strength, Salflex, Tricosal, and others.

The dose of Pepto Bismol (bismuth subsalicylate) 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 Pepto Bismol (bismuth subsalicylate). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Pepto Bismol (bismuth subsalicylate) that you take depends on the strength of the Pepto Bismol (bismuth subsalicylate) 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 oral dosage form (Pepto Bismol suspension):

For diarrhea or upset stomach:
- Adults and children 12 years of age and older—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours.
- Children under 12 years—Should NOT be used in children younger than 12 years of age.

For oral dosage forms (Pepto Bismol tablets or chewable tablets):

For diarrhea or upset stomach:
- Adults and children 12 years of age and older—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours.
- Children under 12 years—Should NOT be used in children younger than 12 years of age.

Usual Adult Dose for Dyspepsia

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
-Shake liquid formulations well before using.

Usual Adult Dose for Traveler’s Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
Shake liquid formulations well before using.

Usual Adult Dose for Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
Shake liquid formulations well before using.

Usual Adult Dose for Helicobacter pylori Infection

524 mg orally 4 times a day.

Usual Pediatric Dose for Diarrhea

Non-specific diarrhea:

<3 years: Ask your doctor
3 to 6 years: Use with caution, 87 mg every 30 minutes to 1 hour as needed.
6 to 9 years: Use with caution, 175 mg every 30 minutes to 1 hour as needed.
9 to 12 years: Use with caution, 262 mg every 30 minutes to 1 hour as needed.

Usual Pediatric Dose for Chronic Diarrhea

Chronic Infantile Diarrhea:

2 to 24 months: Use with caution, 44 mg every 4 hours
24 to 48 months: Use with caution, 87 mg every 4 hours
48 to 70 months: Use with caution, 175 mg every 4 hours

Usual Pediatric Dose for Helicobacter pylori Infection

Dosage in children with Helicobacter Pylori Infection is not well established, the following doses have been used in conjunction with ampicillin and metronidazole.

<= 10 years: 262 mg four times a day for six weeks
> 10 years: 524 mg four times a day for six weeks

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dialysis

Data not available

What should I do if I forget a dose?

Pepto Bismol (bismuth subsalicylate) is usually taken as needed. If your doctor has told you to take Pepto Bismol (bismuth subsalicylate) regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What special dietary instructions should I follow?

Drink plenty of water or other beverages to replace fluids that you may have lost while having diarrhea.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

This medication is usually taken as needed. If your doctor has told you to take bismuth subsalicylate regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Pepto Bismol dosage

Pepto Bismol Liquid

Active Ingredient: Bismuth Subsalicylate 525 mg in each 30 ml dose

Inactive Ingredients: Benzoic Acid, D&C Red No. 22, D&C Red No. 28, Flavor, Gellan Gum, Magnesium Aluminum Silicate, Methylcellulose, Salicylic Acid, Sodium Salicylate, Sorbic Acid, Sucralose, Water

Storage Instructions

Protect from freezing. Avoid excessive heat (over 104°F or 40°C).

Pepto Bismol Liquid Usage Warning

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: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood), diabetes, gout, arthritis. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto Bismol Liquid directions of use

Shake well before use.
Only use dose cup provided.

Pepto Bismol Liquid Dosage

Adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
- Do not exceed 8 doses (240 mL) in 24 hours.
Children under 12 years: ask a doctor.

Pepto-Bismol Swallowable Caplets

Active Ingredient: Bismuth Subsalicylate 262 mg in each caplet

Inactive Ingredients: Calcium Carbonate, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polysorbate 80, Povidone, D&C Red No. 27 Aluminum Lake, Silicon Dioxide, Sodium Starch Glycolate

Storage Instructions

Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Swallowable Caplets Usage Warning

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Swallowable Caplets directions of use

Swallow whole with water, do not chew.

Pepto-Bismol Swallowable Caplets Dosage

Adults and children 12 years and over:
- 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
- Do not exceed 8 doses (16 caplets) in 24 hours.
Children under 12 years: ask a doctor.

Pepto-Bismol Original Chewable Tablets

Active Ingredient: Bismuth Subsalicylate 262 mg in each chewable tablet

Inactive Ingredients: Calcium Carbonate, Flavor, Magnesium Stearate, Mannitol, Povidone, D&C Red No. 27, Saccharin Sodium, Talc

Storage Instructions

Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Original Chewable Tablets Usage Warning

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Original Chewable Tablets directions of use

Chew or dissolve in mouth.

Pepto-Bismol Original Chewable Tablets Dosage

Adults and children 12 years and over:
- 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indgestion and nausea).
- Do not exceed 8 doses (16 tablets) in 24 hours.
Children under 12 years: ask a doctor.

Children’s Pepto Antacid

Active Ingredient: Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet

Inactive Ingredients: D&C Red No.27 Aluminum Lake, Flavor, Magnesium Stearate, Mannitol, Povidone, Sorbitol, Sugar, Talc

Storage Instructions

Do not exceed 25°C. Preserve in well-closed containers.

Children’s Pepto Antacid Chewable Tablets Usage Warning

Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the reach of children.

Children’s Pepto Antacid Chewable Tablets directions of use

Ask a doctor or pharmacist before use.

Children’s Pepto Antacid Chewable Tablets Dosage

Find the right dose on the chart below based on weight (preferred). Otherwise, use age. Repeat dose as needed. Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

Under 24 lbs or under 2 years: Ask a doctor
24-47 lbs or 2-5 years: 1 Children’s Pepto Antacid tablet
48-95 lbs or 6-11 years: 2 Children’s Pepto Antacid tablets
Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period.

Pepto Bismol side effects

Along with Pepto Bismol (bismuth subsalicylate) needed effects, Pepto Bismol (bismuth subsalicylate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Common side effects include:

constipation
dark colored stools
black or darkened tongue.

Check with your doctor immediately if any of the following side effects occur:

In some patients Pepto Bismol (bismuth subsalicylate) may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking this medicine.

Pepto Bismol side effects

anxiety
any loss of hearing
confusion
constipation (severe)
diarrhea (severe or continuing)
difficulty in speaking or slurred speech
dizziness or lightheadedness
drowsiness (severe)
fast or deep breathing
headache (severe or continuing)
increased sweating
increased thirst
mental depression
muscle spasms (especially of face, neck, and back)
muscle weakness
nausea or vomiting (severe or continuing)
ringing or buzzing in ears (continuing)
stomach pain (severe or continuing)
trembling
uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements
vision problems

Nervous system

Rare (less than 0.1%): Myoclonic encephalopathy
Frequency not reported: Weakness, fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, jerky movements, mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, incontinence

Nervous system toxicity is a common feature of bismuth toxicity. Bismuth toxicity is characterized by the insidious onset of weakness and fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, and jerky movements. Acute toxicity may result in the development of mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence.

Myoclonic encephalopathy has occurred in patients who have ingested bismuth for several months to years, but the incidence is very rare. Recovery of patients from bismuth encephalopathy may take several months following discontinuation of use. Bismuth encephalopathy has generally been reported in patients ingesting salts other than subsalicylate.

Other

Salicylism has been reported in patients who chronically ingest bismuth subsalicylate (the active ingredient contained in Pepto-Bismol). Common complaints include vertigo, diminished hearing, lethargy, CNS (central nervous system) dysfunction, confusion, tinnitus, vomiting, and abdominal pain. Patients may present with respiratory alkalosis and metabolic acidosis, azotemia, and hypoprothrombinemia and platelet dysfunction. The elderly may be particularly vulnerable to the development of salicylism.

Frequency not reported: Salicylism

Gastrointestinal

Very common (10% or more): Black stool
Common (1% to 10%): Black tongue
Frequency not reported: Nausea, vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Some side effects can be serious.

If you experience this symptom, stop taking this medication and call your doctor immediately:

ringing or buzzing in your ear(s)
diarrhea lasting longer than 2 days
worsened stomach symptoms.

Pepto Bismol (bismuth subsalicylate) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Human Toxicity Reports

Six examples of poisoning by bismuth subsalicylate were reported ³ arising from treatment of syphilis involving the simultaneous occurrence of stomatitis and albuminuria. The study author noted that bismuth tended to be mobilized during acidosis and advised caution in administration of bismuth to patients subject to acidosis ³.

A case was described in which encephalopathy occurred in a 60 year old man that was attributed to use of bismuth subsalicylate for diarrhea ⁴. The diagnosis was supported by an electroencephalogram and a blood bismuth level of 72 uG/L. The patient recovered completely within one month after the drug was discontinued ⁴.

Inorganic bismuth salts, formed from metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the fetus from normal therapeutic doses, but the data available for bismuth in pregnancy are poor, and the actual fetal risk cannot be determined ². On the other hand, the potential actions of salicylate on the fetus are complex. Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Bioavailability of doxycycline was significantly reduced by 37% and 51% respectively, when bismuth subsalicylate was given simultaneously and as a multiple dose regimen before doxycycline. Bismuth subsalicylate should not be taken when doxycycline is used for therapeutic purposes. The study authors suggest travelers should not take these agents together to prevent diarrhea ⁵.

Pepto Bismol overdose

In case of Pepto Bismol 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 emergency services number.

Moderately toxic and probable oral lethal dose in human is 500mg to 5,000mg per kg body weight for a 70 kg (150 lb) person ⁶.

If you think that you or anyone else may have taken a Pepto Bismol overdose, get emergency help at once. Taking an overdose of Pepto Bismol (bismuth subsalicylate) may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

References

BISMUTH SUBSALICYLATE. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nTtVSk:1
Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 96
Hayes, W.J., Jr., E.R. Laws, Jr., (eds.). Handbook of Pesticide Toxicology. Volume 2. Classes of Pesticides. New York, NY: Academic Press, Inc., 1991., p. 543
HASKING GJ, DUGGAN JM; MED J AUST 2 (AUG 21): 167;1982
Influence of Subsalicylate Bismuth on Absorption of Doxycycline; JAMA 247 (16): 2266; 1982 https://jamanetwork.com/journals/jama/article-abstract/371748
Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-93

Drugs OTC

Zantac

by Health Jade Team on May 27, 2018

What is Zantac

Zantac (Ranitidine) is in a class of medications called histamine-2 blockers (H2 blockers). Zantac active ingredient is called Ranitidine, which is a histamine-2 antagonist or H2 blocker. Zantac (Ranitidine) works by reducing the amount of acid your stomach produces. Histamine is a chemical that occurs naturally in the body. It encourages your stomach to produce acid which it needs to digest your food. By blocking the histamine, Zantac (Ranitidine) reduces the amount of acid your stomach produces. Having less acid in your stomach allows ulcers and inflammation to heal. If your foodpipe (esophagus) has been damaged by stomach acid, this will also have a chance to heal.

Zantac (Ranitidine) is used to treat and prevent ulcers in the stomach and intestines. Zantac (Ranitidine) also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Zantac (Ranitidine) also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn and injury of the food pipe (esophagus).

Over-the-counter Zantac (Ranitidine) is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach.

Key facts

It’s usual to take Zantac (Ranitidine) once or twice a day.
Some people only need to take Zantac (Ranitidine) for a short time, when they have symptoms. Others need to take it for longer.
You can take Zantac (Ranitidine) with or without food.
It’s unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick (nausea). This tends to get better as you carry on taking Zantac (Ranitidine).
Ranitidine is called by the brand names Zantac, Zantac 75, Zantac EFFERdose, Zantac Syrup and Taladine

How long does Zantac take to work

Your indigestion and heartburn should start to feel better within 1 or 2 hours. The effects will usually last for around 12 hours.

It may take a few weeks for Zantac (Ranitidine) to work properly. Depending on your problems, you may still have some acid symptoms during this time.

If you’re taking Zantac (Ranitidine) to prevent stomach ulcers, however, you may not feel any different. Carry on taking your medicine. It will still be working.

How long will I take Zantac for?

If you’re taking lower strength Zantac (Ranitidine) (75mg) that you bought from a pharmacy or supermarket, speak to a pharmacist or doctor before starting on a second packet. They may recommend tests to find out what’s causing your symptoms, if taking Zantac (Ranitidine) hasn’t cleared them up.

If your doctor prescribes Zantac (Ranitidine) for you, you may only need to take it for a few weeks or months, depending on your health problem. Sometimes you might need to take it for longer.

Your doctor may suggest taking Zantac (Ranitidine) only when you have symptoms. This means you won’t have to take it every day. Once you feel better, you can stop taking it – often after a few days or weeks.

Taking Zantac (Ranitidine) this way isn’t suitable for everyone. Speak to your doctor about what’s best for you.

Although Zantac (Ranitidine) appears to only minimally affect the secretion of gastric intrinsic factor, malabsorption of, and resultant deficiency in vitamin B12 may occur during long-term ranitidine therapy ¹.

Zantac side effects long term

It’s usually best to take Zantac (Ranitidine) for a short time. You might take it for a month or two, for example, until your stomach heals. Some people may take it every now and again when they have symptoms. You may find that Zantac (Ranitidine) stops working and your symptoms come back if you take it for longer than this.

If you’re taking Zantac (Ranitidine) to treat Zollinger Ellison syndrome or another long term problem, however, you may need to take it for longer. In this case, follow your doctor’s instructions about the best way to take it.

Are there similar medicines to Zantac?

There are 3 other medicines that are similar to Zantac (Ranitidine). They are cimetidine, famotidine and nizatidine.

Like Zantac (Ranitidine), these medicines are H2 blockers. They work in the same way as Zantac (Ranitidine) to reduce the amount of acid in your stomach.

Famotidine and nizatidine generally work as well as Zantac (Ranitidine) and have similar side effects. However they may suit some people better.

Cimetidine can interfere with lots of medicines and has more side effects than other H2 blockers.

Are there other indigestion medicines?

Yes there are other pharmacy and prescription medicines for indigestion and heartburn.

Antacids, like calcium carbonate (Tums or Mylanta), sodium bicarbonate (Neut), Maalox and Milk of Magnesia, relieve indigestion and heartburn by neutralizing the acid in your stomach. They give quick relief that lasts for a few hours. They’re ideal for occasional stomach acid symptoms.

Some antacids, such as Gaviscon, have an extra ingredient called alginic acid. They work by lining your stomach so that juices from it don’t splash up into your foodpipe. They’re especially good for relieving acid reflux.

Antacids are available from pharmacies and supermarkets.

Proton pump inhibitors (PPIs) reduce the amount of acid made in your stomach, but they do this in a different way to H2 blockers.

They include esomeprazole (Nexium), lansoprazole (Zoton FasTabs), omeprazole (Losec), pantoprazole (Pantoloc Control) and rabeprazole (Pariet).

In general, proton pump inhibitors (PPIs) are used first because they are better than H2 blockers at reducing stomach acid. Your doctor may prescribe an H2 blocker if you don’t get on with a proton pump inhibitor (PPI) – for example because of the side effects.

Lansoprazole and rabeprazole are only available on prescription but you can buy omeprazole, esomeprazole and pantoprazole directly from pharmacies. You can also buy esomeprazole from supermarkets.

Can I take Zantac with other indigestion medicines?

Some antacids are okay to take at the same time as Zantac (Ranitidine). Other antacids, such as Gaviscon, need to be taken a certain amount of time before or after you take the Zantac (Ranitidine). Check the instructions on the packet to see how long you need to wait between medicines.

Sometimes, depending on your symptoms, your doctor may prescribe an H2 blocker as well as a proton pump inhibitor. This will often be for a short time and you’ll usually take the H2 blocker at night.

If you’re prescribed sucralfate (a medicine to treat ulcers), take it at least 2 hours after Zantac (Ranitidine). This is because sucralfate can stop your body from properly absorbing the Zantac (Ranitidine).

Can I drive or ride a bike after taking Zantac?

Occasionally, Zantac (Ranitidine) can make you feel dizzy or sleepy, or give you blurred vision. If this happens to you, don’t drive, cycle or use machinery or tools until you feel better.

Furthermore, the amount of alcohol contained in a large dose of Zantac (Ranitidine) liquid may affect your ability to drive or operate machines. In this case, do not attempt to drive or use any machinery.

Can I drink alcohol with Zantac?

Yes, you can drink alcohol with Zantac (Ranitidine) but be aware that Zantac (Ranitidine) liquid also contains a small amount of alcohol.

Also, drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking Zantac (Ranitidine).

However, it’s best to avoid foods that seem to make your indigestion worse, such as rich, spicy and fatty foods. You may also want to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.

Can lifestyle changes help?

It may be possible to ease symptoms caused by too much stomach acid by making a few changes to your diet and lifestyle:

lose excess weight
don’t eat foods that can make your symptoms worse, such as rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
if you have symptoms at night, try not to eat for at least 3 hours before you go to bed
raise the head of your bed by 10 to 20cm, so your head and chest are higher than your waist

Who can and can’t take Zantac

Zantac (Ranitidine) can be taken by adults. It can also be given to children under 16 years of age on prescription.

Zantac (Ranitidine) isn’t suitable for some people. To make sure that it is safe for you, tell your doctor if you:

have had an allergic reaction to Zantac (Ranitidine) or any other medicines in the past
have kidney problems
have an intolerance to, or cannot absorb, some sugars such as fructose
have been advised to eat a low calcium or low salt diet
cannot have alcohol – Zantac (Ranitidine) liquid contains a small amount of alcohol
have phenylketonuria (PKU), a rare inherited illness

If you’re due to have an endoscopy to find out what’s causing your symptoms, stop taking Zantac (Ranitidine) at least 2 weeks before your procedure. This is because Zantac (Ranitidine) may hide some of the problems that would usually be spotted during an endoscopy.

Pediatric Use

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of Zantac in this age-group is supported by adequate and well-controlled trials in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (aged younger than 1 month) have not been established.

Geriatric Use

Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of Zantac, for which there were subgroup analyses, 4,197 were aged 65 and older, while 899 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function.

Pregnancy and breastfeeding

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

Usually, Zantac (Ranitidine) is safe to take during pregnancy and while breastfeeding. Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy.

If you’re pregnant, it’s always better to try to treat indigestion without taking a medicine.

Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.

If these lifestyle changes don’t work, you may be recommended a medicine like Zantac (Ranitidine).

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zantac (Ranitidine). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Zantac (Ranitidine) was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Zantac and breastfeeding

Zantac (Ranitidine) is safe to take while you’re breastfeeding. It passes into breast milk, but only in small amounts which aren’t harmful to the baby.

However, if your baby is premature or has health problems check with your doctor first.

Cautions with other medicines

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

Some medicines can interfere with Zantac (Ranitidine) and make you more likely to have side effects.

Tell your doctor if you’re taking these medicines before you start taking Zantac (Ranitidine):

anti-fungal medicines such as itraconazole, ketoconazole or posaconazole
any medicine used to treat cancer
HIV medicines

Zantac (Ranitidine) has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Procainamide: Zantac (Ranitidine), a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of Zantac (Ranitidine) (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual Zantac (Ranitidine) doses, it may be prudent to monitor for procainamide toxicity when administered with oral Zantac (Ranitidine) at a dose exceeding 300 mg per day.

Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and Zantac (Ranitidine) therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with Zantac (Ranitidine).

Zantac (Ranitidine) may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.

Gefitinib: Gefitinib exposure was reduced by 44% with the coadministration of Zantac (Ranitidine) and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral Zantac (Ranitidine). Use appropriate clinical monitoring when initiating or discontinuing Zantac (Ranitidine).

Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral Zantac (Ranitidine) was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of Zantac (Ranitidine) (150 mg twice daily) is unknown.

Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. However, in another interaction trial in 8 volunteers receiving IV midazolam, a 300-mg oral dose of Zantac (Ranitidine) increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when Zantac (Ranitidine) is coadministered with oral midazolam.

Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.

These are not all the medicines that may not mix well with Zantac (Ranitidine). For a full list see the leaflet inside your medicines packet.

Mixing Zantac (Ranitidine) with herbal remedies and supplements

There isn’t enough research to know if complementary medicines and herbal remedies are safe to take with Zantac (Ranitidine).

What is Zantac used for

Zantac (Ranitidine) comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. It is usually taken once a day at bedtime or two to four times a day. Over-the-counter Zantac (Ranitidine) comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zantac (Ranitidine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve Zantac (Ranitidine) effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter Zantac (Ranitidine) for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking Zantac (Ranitidine) and call your doctor.

Zantac (Ranitidine) is also used sometimes to treat upper gastrointestinal bleeding and to prevent stress ulcers, stomach damage from use of nonsteroidal anti-inflammatory drugs (NSAIDs), and aspiration of stomach acid during anesthesia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Zantac uses

Zantac (Ranitidine) reduces the amount of acid your stomach makes.

Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year.
Treatment of gastro-esophageal reflux disease (GERD). Symptomatic relief commonly occurs within 24 hours after starting therapy with Zantac 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Zantac 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Zantac (Ranitidine) is also taken to prevent and treat stomach ulcers.

Sometimes, Zantac (Ranitidine) is taken for a rare illness caused by a tumor in the pancreas or gut called Zollinger-Ellison syndrome.

Zantac (Ranitidine) comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.

All types of Zantac (Ranitidine) are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.

Before taking Zantac – Precautions

tell your doctor and pharmacist if you are allergic to Zantac (Ranitidine) or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had porphyria, phenylketonuria, or kidney or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Zantac (Ranitidine), call your doctor.
Using Zantac may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

How and when to take Zantac

It’s usual to take Zantac (Ranitidine) twice a day – 1 dose in the morning and 1 dose in the evening. Some people only need to take Zantac (Ranitidine) once a day, at bedtime.

Very young babies, and people with Zollinger-Ellison syndrome, usually take Zantac (Ranitidine) 3 times a day. People with severe inflammation of the food pipe (esophagitis) may need to take it 4 times a day.

How to take Zantac

Take Zantac 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.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it.

You can take Zantac (Ranitidine) with or without food. However, if you get symptoms whenever you eat or drink, take your medicine 30 minutes to 60 minutes before having a drink, snack or meal.

Tablets – swallow tablets whole with a glass of water, milk or juice.
Soluble tablets – dissolve tablets in half a glass of water. Do not use milk, fizzy water or other fizzy drinks. Wait until the medicine has completely dissolved and then drink it straight away.
Liquid – this comes with a syringe or spoon to help you measure it. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it won’t give you the right amount.

Liquid Zantac (Ranitidine) is suitable for children and people who find it difficult to swallow tablets.

Do not crush, chew, or break the Zantac effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the Zantac effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child’s mouth.

Zantac granules should be mixed with 6 to 8 ounces of water before drinking.

Measure Zantac liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Zantac.

Store Zantac at room temperature away from moisture, heat, and light.

How much Zantac will I take?

Each tablet contains 75mg, 150mg or 300mg of Zantac (Ranitidine). You can buy 75mg tablets in pharmacies and supermarkets. Soluble tablets, and 150mg and 300mg tablets are only available on prescription.

The usual dose to treat:

indigestion or heartburn is 75mg to 300mg a day
stomach ulcers and inflammation of the food pipe is 300mg to 600mg a day
Zollinger-Ellison syndrome is 450mg to 6 grams a day

Zantac (Ranitidine) liquid comes in 2 different strengths – your daily dose will depend on what your doctor prescribes. Follow your doctor’s advice about how much Zantac (Ranitidine) to take and when.

Doses are usually lower for children and people with kidney problems.

If a doctor prescribes Zantac (Ranitidine) for your child, they will use your child’s weight or age to work out the right dose.

Zantac Dosage

Active Duodenal Ulcer:

The current recommended adult oral dosage of Zantac for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain.

Maintenance of Healing of Duodenal Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer Zantac 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer:

The current recommended adult oral dosage is 150 mg twice daily.

Maintenance of Healing of Gastric Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Gastro-esophageal reflux disease (GERD):

The current recommended adult oral dosage is 150 mg twice daily.

Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Zantac in neonatal patients (aged younger than 1 month) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications.

Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.

Dosage Adjustment for Patients with Impaired Renal Function:

On the basis of experience with a group of subjects with severely impaired renal function treated with Zantac, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function.

Will my dose go up or down?

Sometimes your doctor will increase your dose of Zantac (Ranitidine) if it isn’t working well enough.

Depending on the reason you take Zantac (Ranitidine), you may take a higher dose to start with – usually for at least 1 month. After this, your doctor may recommend a lower dose.

What if I forget to take Zantac?

If you usually take it:

once a day, take the missed dose as soon as you remember, unless it’s less than 12 hours until your next dose – in which case skip the missed dose
twice a day, take the missed dose as soon as you remember, unless it’s nearly time for your next dose – in which case skip the missed dose
3 or 4 times a day, skip the missed dose and take your next dose as normal

Do NOT take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember your medicine.

What if I take too much Zantac?

Zantac (Ranitidine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get some side effects, such as feeling sick. Call your doctor if you’re worried, or you’re bothered by side effects.

Zantac dosage

Zantac 75

Active ingredient (in each tablet): Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

Blister: do not use if individual blister unit is open or torn
Bottle: do not use if printed foil under bottle cap is open or torn
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Zantac 75 Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Zantac 75 Directions of Use

Adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
- to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
Children under 12 years: ask a doctor

Zantac 75 can be taken 30 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, or it can be taken when heartburn symptoms strike, providing relief in as little as 30 minutes and lasting up to 12 hours.

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Zantac 75 Warnings

Allergy alert

Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have:

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Stop use and ask a doctor if:

your heartburn continues or worsens
you need to take this product for more than 14 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.

Maximum Strength Zantac 150

Active ingredient (in each tablet): Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

Blister: do not use if individual blister unit is open or torn
Bottle: do not use if printed foil under bottle cap is open or torn
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Maximum Strength Zantac 150 Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Maximum Strength Zantac 150 Directions of Use

Adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
- to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
Children under 12 years: ask a doctor

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Maximum Strength Zantac 150 Warnings

Allergy alert

Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have:

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Stop use and ask a doctor if:

your heartburn continues or worsens
you need to take this product for more than 14 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.

Zantac side effects

Most people who take Zantac (Ranitidine) do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking Zantac (Ranitidine).

The following side effects aren’t common and may happen in more than 1 in 1,000 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

stomach pains
constipation
feeling sick (nausea)
headache
diarrhea
vomiting

Zantac (Ranitidine) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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

The following have been reported as events in clinical trials or in the routine management of patients treated with Zantac. The relationship to therapy with Zantac has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Zantac.

Central Nervous System

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular

As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Zantac (Ranitidine) should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal

Rare reports of arthralgias and myalgias.

Hematologic

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Zantac and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Zantac has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving Zantac, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared with patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI: 1.07–2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Serious side effects

Serious side effects are very rare and happen in less than 1 in 10,000 people. Call a doctor straight away if you have:

stomach pain that seems to be getting worse – this can be a sign of an inflamed liver or pancreas
back pain, fever, pain when peeing or blood in your pee – these can be signs of kidney problems
a rash, swollen joints or kidney problems – these can be signs that your small blood vessels are swollen (vasculitis)
a slow or irregular heartbeat

Serious allergic reaction

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

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

How to cope with side effects

What to do about:

stomach pains – try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your tummy may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
constipation – eat more high-fiber foods such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example, by going for a daily walk or run. If this doesn’t help, talk to your pharmacist or doctor.
feeling sick – it may help if you don’t eat rich or spicy food while you’re taking Zantac (Ranitidine).

Human Toxicity Reports

Headache (sometimes severe) occurs in approx 3% of patients receiving the drug ². Malaise, dizziness, somnolence, insomnia, and vertigo have been reported less frequently. Reversible mental confusion, agitation, mental depression, and hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski’s sign, diaphoresis, and bradycardia, which resolved within 24 hr after discontinuance of the drug.

Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been reported rarely ².

Rash, which may be urticarial, maculopapular, and/or pruritic, has been reported during ranitidine therapy ². Rash suggestive of mild erythema multiforme has occurred rarely. Urticaria at the site of injection has occurred following IV admin of ranitidine. Alopecia has occurred rarely ².

Leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, aplastic anemia, acquired immune hemolytic anemia, and pancytopenia, which may be accompanied by bone marrow hypoplasia, have been reported rarely in patients receiving ranitidine ². Alterations in blood cell counts usually were reversible. At least one case of leukocytosis has been reported 6-8 days after initiating ranitidine therapy, which resolved following discontinuance ². Aplastic anemia has occurred in at least one patient receiving ranitidine ².

Small increases in serum creatinine, without concomitant increases in BUN, have been reported during ranitidine therapy ². Increases in serum aminotransferase, alkaline phosphatase, LDH, total bilirubin, and gamma-glutamyl transferase concentration have been reported and reversible hepatitis, which may be hepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice, has occurred occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely ².

A 63 yr old woman developed anicteric hepatitis after two wk of therapy with ranitidine ³. Despite continuation of therapy, her symptoms resolved within 5 days and transaminase levels returned to normal in the next 4 weeks, at which time use of the drug ceased. No other cause for the reaction could be found ³.

Cardiac arrhythmias have occurred rarely in patients receiving ranitidine ². Bradycardia, sometimes assoc with dyspnea, has occurred ². Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported rarely ².

Arthralgias, myalgias, and hypersensitivity reactions such as bronchospasm, fever, rash, and eosinophilia have occurred rarely in patients receiving ranitidine ². Anaphylaxis, characterized by severe urticaria and a decrease in blood pressure in one patient following administration of a single dose of ranitidine, has occurred rarely; exacerbation of asthma and angioedema also has occurred ². Mild erythema multiforme-like rash and alopecia also have occurred rarely. Rare reports suggest that ranitidine may precipitate acute attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria ².

In a study of 51 male patients with duodenal ulcer, treatment with ranitidine, produced no decrease in basal levels of serum testosterone, as did cimetidine ⁴.

Ranitidine inhibited in a dose-dependent manner acetylcholinesterases from human erythrocytes and gastric mucosa ⁵. Pseudocholinesterase in serum was also inhibited, the levels required were about 25 times higher. A stimulation of cholinergic mechanisms in ranitidine treatment should occur, e.g, stimulation of glandular secretion or increase of gastrointestinal motility ⁵.

Symptoms of acute intoxication with both cimetidine and ranitidine are bradycardia and tachycardia ⁶; CNS disturbances, including confusion, delirium, drowsiness, slurred speech, flushing, and sweating; dermatologic lesions; endocrine abnormalities; GI disorders; and liver dysfunction ⁶.

Most controlled studies in humans indicate that ranitidine does not alter theophylline metabolism, even at high doses ⁷. However, there have been several case reports published recently which demonstrate the development of theophylline toxicity mostly in older patients receiving stable oral doses of this drug when ranitidine was administered simultaneously ⁷. A study involving eleven elderly (mean age, 69.0 + or – 6.2 years) patients with chronic obstructive pulmonary disease (COPD). During one week the patients took slow-release theophylline, 200 mg every 12 hr, followed by one week intake of the same dose of theophylline plus ranitidine tablets, 150 mg every 12 hr. At the end of each period, blood samples were obtained 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12 hr after the morning dose for the determination of serum theophylline levels. The peak theophylline concentration (Tmax) was achieved after 4.1 + or – 0.9 hr while the patients were taking theophylline, and after 2.9 + or – 1.4 hr with the combined regimen. This difference was statistically significant. In only 3/11 subjects did Tmax remain unchanged during both phases of the study. The mean theophylline clearance rates while the patients were receiving theophylline alone (39.58 + or – 19.89 ml/min) and when they were receiving both medications 134.42 + or – 10.55 ml/min) were similar. The mean serum levels while the patients were receiving theophylline alone were slightly higher but not statistically different. These results suggest that the reported increases in serum theophylline levels in older patients receiving theophylline and ranitidine cannot be ascribed to slower theophylline metabolism in the geriatric patients with chronic obstructive pulmonary disease who is also given ranitidine ⁷.

A case report of acute cholestatic hepatitis associated with rash and hypereosinophilia, in which the absence of transfusion, intercurrent viral infection, alcohol consumption or other hepatotoxic drugs are suggestive of ranitidine-induced hepatotoxicity ⁸. The pathogenesis of the disorder is unknown, but the lack of a dose-effect relationship, the rarity and unpredictability of the reaction, as well as the clinical signs suggest that hypersensitivity is involved. Physicians should be aware of this rare and idiosyncratic side-effect of ranitidine ⁸.

Although acute interstitial nephritis has been well described with the histamine H2-receptor antagonist cimetidine, a study authors found only one previous case report of ranitidine-induced interstitial nephritis in the literature ⁹. They describe an additional patient who developed acute interstitial nephritis after taking ranitidine ⁹. Electron microscopy showed focal fusion of the epithelial cell foot processes that was not described in the previous report of ranitidine-induced interstitial nephritis.

Reversible hematologic abnormalities including hemolytic anemia ¹⁰ with a positive direct Coombs’ test have been associated with ranitidine. In addition to the case report cited above, the US Food and Drug Administration had received five other cases of hemolysis associated with recent intake of ranitidine as of February 1991 ¹⁰. To investigate the possible association of ranitidine with autoimmune hemolytic anemia, a study was conducted to determine how often diagnoses of hemolytic anemia or abnormal Coombs’ test results followed dispensing of ranitidine using the automated medical and pharmacy records of a large health maintenance organization. No occurrences of hemolytic anemia were identified among 12,054 individuals following 38,686 prescriptions for this medication. The 95% upper confidence bound was 3.1 cases/10,000 exposed persons. One abnormal direct Coombs test with mild anemia was discovered during routine prenatal testing of an asymptomatic patient who was dispensed ranitidine two and a half months previously. Hemolysis, however, was not demonstrated and an association with prior ranitidine use could not be confirmed. Additional analyses indicate that in only 30% of ranitidine courses was a blood count obtained. In those courses with hematocrits below 40%, less than 1% had a Coombs’ test performed. Chart review suggests that the majority of individuals with severe anemia have alternative explanations other than autoimmune hemolysis for their anemia ¹⁰. This analysis indicates that ranitidine is unlikely to be a common cause of clinically recognized autoimmune hemolytic anemia and demonstrates the utility of large automated medical and pharmacy data bases to conduct post-marketing studies of spontaneously reported drug effects.

Zantac overdose

Zantac (Ranitidine) overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience. In addition, abnormalities of gait and hypotension have been reported.

Symptoms of an Zantac (Ranitidine) overdose are:

Abnormal heartbeat, including rapid or slow heartbeat
Drowsiness, confusion
Diarrhea
Difficulty breathing
Dilated pupils
Flushing
Low blood pressure
Nausea, vomiting
Slurred speech
Sweating

Seek medical help right away. DO NOT make the person throw up unless poison control or a health care provider tells you to.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of Zantac in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

What to Expect at the Emergency Room

Take the container with you to the hospital, if possible.

The provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated. The person may receive:

Activated charcoal
Blood and urine tests
Breathing support, including oxygen
Chest x-ray
ECG (electrocardiogram, or heart tracing)
Intravenous fluids (through a vein)
A laxative
Medicine to treat symptoms
Tube through the mouth into the stomach to empty the stomach (gastric lavage)

Outlook (Prognosis)

Serious complications are rare. These are generally safe medicines, even when taken in large doses.

References

McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2184
McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2182
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Peden NR et al; Acta Endocrinol (Copenh) 96 (4): 564-8;1981 http://www.eje-online.org/content/96/4/564.long
Hansen WE, Bertl S; Z Gastroenterol 21 (4): 164-7;1983 https://www.ncbi.nlm.nih.gov/pubmed/6306938
Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 824
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Gaughan WJ et al; Am J Kidney Dis 22 (2): 337-40;1993 https://www.ncbi.nlm.nih.gov/pubmed/8352263
Choo PW et al; J Clin Epidemiol 47 (lO): 1175-9; 1994 ttps://www.ncbi.nlm.nih.gov/pubmed/7722551