Midol Complete- Acetaminophen, Caffeine, And Pyrilamine Maleate Tablet

Midol Complete- Acetaminophen, Caffeine, And Pyrilamine Maleate Tablet
SPL v6
SPL
SPL Set ID d20425a4-f074-4154-e053-2995a90ae9fd
Route
ORAL
Published
Effective Date 2021-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)
Inactive Ingredients
Fd&c Blue No. 2 Carnauba Wax Propylene Glycol Hypromellose, Unspecified Microcrystalline Cellulose Shellac Triacetin Croscarmellose Sodium Magnesium Stearate Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Midol Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-10-19 Until 2024-12-31
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Section 55105-1
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Caffeine 60 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine

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
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
Drug Facts

Drug Facts

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.

Liver Warning

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
Other Information

store at room temperature

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 Or Comments?

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

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

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

Keep Out of Reach of Children.

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.

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
Principal Display Panel 25 Caplet Pouch Box

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

25 POUCHES 2 CAPLETS EACH

Principal Display Panel 30 Caplet Pouch Box

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

30 POUCHES 2 CAPLETS EACH

Principal Display Panel 4 Caplet Pouch Package

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

4

Caplets

Principal Display Panel 2 Caplet Pouch Package

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

2

Caplets

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.

Structured Label Content

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Caffeine 60 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine

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
Do Not Use (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
Drug Facts

Drug Facts

Allergy Alert (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.

Liver Warning

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
Other Information

store at room temperature

Inactive Ingredients (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 Or Comments? (QUESTIONS OR COMMENTS?)

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

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Ask A Doctor Before Use If You Have (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
Principal Display Panel 25 Caplet Pouch Box (PRINCIPAL DISPLAY PANEL-25 Caplet Pouch Box)

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

25 POUCHES 2 CAPLETS EACH

Principal Display Panel 30 Caplet Pouch Box (PRINCIPAL DISPLAY PANEL-30 Caplet Pouch Box)

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

30 POUCHES 2 CAPLETS EACH

Principal Display Panel 4 Caplet Pouch Package (PRINCIPAL DISPLAY PANEL-4 Caplet Pouch Package)

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

4

Caplets

Principal Display Panel 2 Caplet Pouch Package (PRINCIPAL DISPLAY PANEL- 2 Caplet Pouch Package)

Midol ®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

2

Caplets

Ask A Doctor Or Pharmacist Before Use If You Are (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.

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:09.135427 · Updated: 2026-03-14T23:04:38.930408