Midol®

Midol®
SPL v1
SPL
SPL Set ID 1bf96671-9233-4b17-9d4c-d26982ca45be
Route
ORAL
Published
Effective Date 2022-04-18
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
Carnauba Wax Croscarmellose Sodium Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Propylene Glycol Shellac Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: MIDOL Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-10
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
  • fatigue
  • backache
  • muscle aches
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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

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
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. Avoid temperatures above 25°C (77°F).
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 9-5 EST)

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
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
Principal Display Panel 2 Caplet Pouch Blister Pack

Midol®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

NEW LOOK

2 Caplets

Single-Pack

Structured Label Content

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • fatigue
  • backache
  • muscle aches
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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

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
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 (Other information)
  • store at room temperature. Avoid temperatures above 25°C (77°F).
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 9-5 EST)

When Using This Product (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 (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
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
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
Principal Display Panel 2 Caplet Pouch Blister Pack (PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Blister Pack)

Midol®

COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

NEW LOOK

2 Caplets

Single-Pack

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:11.433537 · Updated: 2026-03-14T23:00:33.718954