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Midol

acetaminophen, caffeine, and pyrilamine maleate · Midol is a central nervous system stimulant (over-the-counter) containing acetaminophen, caffeine, and pyrilamine maleate, made by Navajo Manufacturing Company Inc..

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
1
+ 1 repackager labels

for the temporary relief of these symptoms associated with menstrual periods: • cramps • bloating • water-weight gain • headache • backache • muscle aches • fatigue

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

(in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg Purpose Pain reliever Diuretic Antihistamine

Purpose

Pain reliever Diuretic Antihistamine

Uses

For the temporary relief of these symptoms associated with menstrual periods:

  • Cramps
  • Bloating
  • Water-weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue

Directions

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

Warnings

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.

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

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

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

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

Pregnancy 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Questions?

1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet500 mg / 60 mg / 15 mgoral1

Manufacturers and labels

1 FDA label · 1 from repackagers

    Repackager labels (1)
    • Navajo Manufacturing Company Inc.04/08/2026

    Midol: common questions

    What is Midol used for?
    for the temporary relief of these symptoms associated with menstrual periods: • cramps • bloating • water-weight gain • headache • backache • muscle aches • fatigue
    Is Midol a prescription drug?
    No. Midol is sold over the counter (OTC) without a prescription.
    Are there other products with the same active ingredient as Midol?
    Yes. Other FDA-listed products with the same active ingredients include Menstrual Complete, Menstrual Relief, Menstrual Complete, Menstrual Complete Maximum Strength.
    Who makes Midol?
    Navajo Manufacturing Company Inc. lists Midol with the FDA.

    Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/08/2026 · Label text is shown as published by the manufacturer. Not medical advice

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