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Over-the-counter medicine · no prescription needed

Acetaminophen, caffeine and pyrilamine

Purpose on the label: Pain reliever Diuretic Antihistamine

Allergy

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Acetaminophen, caffeine and pyrilamine used for?
The Drug Facts label of Menstrual Complete (Allegiant Health) lists these uses: (s) for the temporary relief of these symptoms associated with menstrual periods; water-weight gain; backache; muscle aches; cramps; fatigue; headache; bloating.
Do I need a prescription for Acetaminophen, caffeine and pyrilamine?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Acetaminophen, caffeine and pyrilamine been recalled?
FDA enforcement reports list 2 recalls of products on this page; the newest started April 26, 2012. A recall usually concerns specific products or lots, not every brand.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Menstrual Complete · Allegiant Health

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg, tablet, film coated (oral)

Active ingredient (s)

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Purpose

Pain reliever Diuretic Antihistamine

Uses

(s) for the temporary relief of these symptoms associated with menstrual periods:

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

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • 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

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • 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 heart rate. 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 These could be signs of a serious condition.

If pregnant or breastfeeding

a health professional before use.

Keep out of reach of children

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

Directions

  • do not take more than directed
  • adults and children 12 years and over:
  • 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

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions?

/Comments 1-888-952-0050

— FDA label of Menstrual Complete, Allegiant Health, effective November 5, 2024. See the official label on DailyMed →

Menstrual Complete · Strive Pharmaceuticals Inc.

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg, tablet (oral)

Active ingredient (in each gelcap)

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

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

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 6 gelcaps 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

  • Overdose warning: 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 children even if you do not notice any signs or symptoms.

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and older: take 2 gelcaps with water. Repeat every 6 hours as needed. Do not exceed 6 gelcaps per day
  • children under 12 years: consult a doctor

Inactive ingredients

croscarmellose sodium, D&C red#33 aluminium lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, Isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions?

1-888-577-8033 Monday - Friday 8am - 4pm EST

— FDA label of Menstrual Complete, Strive Pharmaceuticals Inc., effective March 7, 2024. See the official label on DailyMed →

Dolex Fem · Pharmadel LLC

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg, tablet, coated (oral)

Active ingredient

& Purposes . Active ingredients (in each tablet) Purposes Acetaminophen 500mg............................ Pain reliever Caffeing 60mg ......................................... Diuretic Pyrilamine maleate 15mg......................... Anthistamine

Purpose

Active ingredients (in each tablet) Purposes Acetaminophen 500mg............................ Pain reliever Caffeing 60mg ......................................... Diuretic Pyrilamine maleate 15mg......................... Anthistamine

Uses

For the temporary relief of these symptoms associated with menstrual periods cramps bloating water- weight gain headache backache Muscle aches fatigue

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets 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 If a skin or general allergic reaction occurs, stop use and seek medical help right away.
  • 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 heart beat.

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 allergic to any of the ingredients in this product

Ask a doctor before use if

you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

new symptoms occur redness or swelling is present pain gets worse or lasts more than 7 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 an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dose adultos and children 12 years of age and over: take two (2) caplets, every 6 hours, do not exceed 6 caplets in a 24- hour period children under 12 years of age: do not use

Inactive ingredients

corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water

Questions?

Other information Store at room temperature 77-86°F (25-30°C) Questions or comments? 1-866-359-3478 (M-F) 9AM - 5PM or www.pharmadel.com *This product is not manufactured or distributed by Bayer Healthcare LLC owner of the registered trademark MidolⓇ Complete.

— FDA label of Dolex Fem, Pharmadel LLC, effective February 5, 2026. See the official label on DailyMed →

Acetaminophen , Caffeine and pyrilamine maleate · Softgel Healthcare Pvt Ltd

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg, capsule (oral)

Active ingredient (in each gelcap)

Acetaminophen USP 500mg Caffeine USP 60mg Pyrilamine maleate USP 15mg

Purpose

Pain reliever Diuretic Antihistamine

Uses

for the temporary relief of these symptoms associated with menstural periods:

  • cramps
  • bloating
  • waterweight gain
  • headache
  • backache
  • muscle aches
  • fatigue

Warnings

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

  • more than 6 gelcap 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:
  • hives
  • blisters
  • rash
  • skin reddening
  • 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 beacuse 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

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

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and older: take 2 gelcap with water
  • repeat every 6 hours as needed
  • do not exceed 6 gelcap per day
  • children under 12 years: consult a doctor

Other information

store at room temperature.

Inactive ingredients

croscarmellose sodium, D&C red 33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue 1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin.

— FDA label of Acetaminophen , Caffeine and pyrilamine maleate, Softgel Healthcare Pvt Ltd, effective February 9, 2026. See the official label on DailyMed →

Acetaminophen , Caffeine and pyrilamine maleate · Softgel Healthcare Pvt Ltd

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg, capsule, liquid filled (oral)

Active ingredient (in each softgelatin capsule)

Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg

Purpose

Pain reliever Diuretic Antihistamine

Uses

for the temporary relief of these symptoms associated with menstural periods:

  • cramps
  • bloating
  • waterweight gain
  • headache
  • backache
  • muscle aches
  • fatigue

Warnings

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

  • more than 6 softgel 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:
  • hives
  • blisters
  • rash
  • skin reddening
  • 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 beacuse 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

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

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and older: take 2 softgel with water
  • repeat every 6 hours as needed
  • do not exceed 6 softgel per day
  • children under 12 years: consult a doctor

Other information

store at room temperature.

Inactive ingredients

croscarmellose sodium, D&C red 33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue 1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin.

— FDA label of Acetaminophen , Caffeine and pyrilamine maleate, Softgel Healthcare Pvt Ltd, effective April 27, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg · tablet, film coated (oral) · 30 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Comfort-Time Time Cap Labs, Inc DailyMed
Menstrual Complete Allegiant Health DailyMed
Menstrual Complete Chain Drug Marketing Association, Inc. DailyMed
Menstrual Complete Discount Drug Mart DailyMed
Menstrual Complete Family Dollar Services Inc DailyMed
Menstrual Complete H E B DailyMed
Menstrual Complete Kroger Company DailyMed
Menstrual Complete L.N.K. International, Inc. —
Menstrual Complete Meijer Distribution, Inc. DailyMed
Menstrual Complete Rite Aid Corporation DailyMed
Menstrual Complete Topco Associates, LLC DailyMed
Menstrual Complete Walmart Inc. —
Menstrual Complete WinCo Foods, LLC DailyMed
Menstrual Complete Maximum Strength Chain Drug Marketing Association Inc DailyMed
Menstrual Complete Maximum Strength L.N.K. International, Inc. DailyMed
Menstrual Complete Maximum Strength Rite Aid Corporation DailyMed
Menstrual Complete Pain Relief Walgreen Company DailyMed
Menstrual Pain Relief Walgreen Company DailyMed
Menstrual Pain Relief Complete Shield Pharmaceuticals Corp DailyMed
Menstrual Relief Better Living Brands, LLC DailyMed
Menstrual Relief CVS Pharmacy DailyMed
Menstrual Relief Cvs Woonsocket Prescription Center, Incorporated DailyMed
Menstrual Relief Dolgencorp, LLC DailyMed
Menstrual Relief Geiss, Destin & Dunn Inc. DailyMed
Menstrual Relief Target Corporation DailyMed

Showing 25 of 29 brands.

Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg · tablet (oral) · 14 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg Walgreens Co. DailyMed
FLO PMS Complete O Positiv, Inc. DailyMed
Menstrual Complete Kroger —
Menstrual Complete Pioneer Life Sciences, LLC DailyMed
Menstrual Complete Strive Pharmaceuticals Inc. DailyMed
Midol Navajo Manufacturing Company Inc. DailyMed
Midol Complete Acme United Corporation DailyMed
Midol Complete Bayer HealthCare LLC. DailyMed
Midol Complete Lil' Drug Store Products, Inc DailyMed
Midol Complete R J General Corporation DailyMed
Midol Complete Select Consumer Group DailyMed
Midol Complete, Travel BASIX Lil' Drug Store Products, Inc DailyMed
Multi-Symptom Menstrual Relief Target DailyMed
Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg · tablet, coated (oral) · 7 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Buscapina Opmx LLC DailyMed
Dolex Fem Pharmadel LLC DailyMed
Menstrual Complete Healthlife of USA DailyMed
Midol Complete Gelcaps Bayer HealthCare LLC DailyMed
Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg · capsule (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Acetaminophen , Caffeine and pyrilamine maleate Softgel Healthcare Pvt Ltd DailyMed
Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 15 mg · capsule, liquid filled (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Acetaminophen , Caffeine and pyrilamine maleate Softgel Healthcare Pvt Ltd DailyMed
Acetaminophen 500 mg · Caffeine 60 mg · Pyrilamine maleate 500 mg · tablet, film coated (oral) · 1 product
Brand or product nameCompany on the labelLabel
Buscapina Opmx LLC —

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Opmx LLC5 products
  • Walgreen Company3 products
  • Lil' Drug Store Products, Inc3 products
  • Bayer HealthCare LLC.2 products
  • Rite Aid Corporation2 products
  • Chain Drug Marketing Association, Inc.2 products
  • United Natural Foods, Inc. dba UNFI2 products
  • Shield Pharmaceuticals Corp2 products
  • Softgel Healthcare Pvt Ltd2 products
  • L.N.K. International, Inc.2 products
  • Target Corporation1 product
  • Select Consumer Group1 product
  • Kroger1 product
  • Strive Pharmaceuticals Inc.1 product
  • Better Living Brands, LLC1 product
  • Pharmadel LLC1 product
  • Meijer Distribution, Inc.1 product
  • CVS Pharmacy1 product
  • Navajo Manufacturing Company Inc.1 product
  • Allegiant Health1 product
  • Healthlife of USA1 product
  • O Positiv, Inc.1 product
  • Laboratorios Sanfer, S.A. de C.V.1 product
  • Acme United Corporation1 product
  • Kroger Company1 product
  • H E B1 product
  • Topco Associates, LLC1 product
  • Time Cap Labs, Inc1 product
  • Dolgencorp, LLC1 product
  • Walgreens Co.1 product

Showing the 30 companies with the most products, of 39.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. April 26, 2012 · Class III · Terminated · D-1424-2012

    Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

    Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25) — Bayer Healthcare, LLC

  2. April 26, 2012 · Class III · Terminated · D-1423-2012

    Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

    Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 — Bayer Healthcare, LLC

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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