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.

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

Midol Caffeine Free Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: Ask a doctor

What do I do if I miss a dose?

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

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

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

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Other side effects of Midol Caffeine Free

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

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

Midol Long Lasting Relief

Active ingredients (in each caplet): Acetaminophen 650 mg (Pain reliever)

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Midol Long Lasting Relief Uses

Temporarily relieves minor aches and pains due:

• Temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• Temporarily reduces fever

Liver warning

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

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if you have liver disease.

Allergy Alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

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

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
• If you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition

As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

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

Midol Long Lasting Relief Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• Children under 12 years: Ask a doctor

Midol side effects

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

• Feeling sleepy.
• Feeling nervous and excitable.

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

Rare side effects

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

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Midol Overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

References

1. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
2. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
3. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/
4. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
5. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
6. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
7. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/
8. Pyrilamine maleate. https://pubchem.ncbi.nlm.nih.gov/compound/pyrilamine_maleate