midol ®

midol ®
SPL v2
SPL
SPL Set ID 177d78c7-871c-cb39-e063-6394a90aab24
Route
oral
Published
Effective Date 2021-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) bromotheophylline (25 mg) pyrilamine (15 mg)
Inactive Ingredients
carnauba wax croscarmellose sodium hypromelloses magnesium stearate cellulose, microcrystalline propylene glycol shellac titanium dioxide triacetin

Identifiers & Packaging

Pill Appearance
Imprint: MCC Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-01-29

Description

Drug Facts


Medication Information

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
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
Other Information

Store at room temperature. Avoid temperatures above 25 oC (77 oF).

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Description

Drug Facts

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
Pamabrom 25 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine
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
Allergy Alert

acetamonophen 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

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
Questions Or Comments?

1-800-331-4536 (Mon-Fri 9AM - 5PM 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
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 24 Caplet Blister Carton

Midol ®



Complete

Caffeine Free

Acetaminophen/Pamabrom/Pyrilamine Maleate



Pain Reliever/Diuretic/Antihistamine



MULTI-SYMPTOM RELIEF OF

CRAMPS, BLOATING



HEADCACHE, BACKACHE

24 CAPLETS


Structured Label Content

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
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
Other Information (Other information)

Store at room temperature. Avoid temperatures above 25 oC (77 oF).

Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

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
Pamabrom 25 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine
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
Allergy Alert

acetamonophen 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
Questions Or Comments? (Questions or comments?)

1-800-331-4536 (Mon-Fri 9AM - 5PM 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
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 24 Caplet Blister Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Carton)

Midol ®



Complete

Caffeine Free

Acetaminophen/Pamabrom/Pyrilamine Maleate



Pain Reliever/Diuretic/Antihistamine



MULTI-SYMPTOM RELIEF OF

CRAMPS, BLOATING



HEADCACHE, BACKACHE

24 CAPLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)