Quality Choice 44-679

Quality Choice 44-679
SPL v3
SPL
SPL Set ID 6a945066-7714-45c0-9225-a921879f6a45
Route
ORAL
Published
Effective Date 2025-09-04
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
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Blue No. 2 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Shellac Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;679 Shape: oval Color: purple Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-21

Description

Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Purpose

Pain reliever Diuretic Antihistamine


Medication Information

Purpose

Pain reliever

Diuretic

Antihistamine

Description

Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Uses

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

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • irritability
  • water-weight gain
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.

Directions
  • do not take more than directed
  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
  • children under 12 years: ask a doctor
Do Not Use
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC

QUALITY®

CHOICE

NDC 63868-961-20

Compare to the Active Ingredients

in Maximum Strength Pamprin®

Multi-Symptom*

Maximum Strength

Menstrual Pain Relief

Multi-Symptom

Acetaminophen - Pain Reliever

Pamabrom - Diuretic

Pyrilamine Maleate - Antihistamine

Relieves: Cramps, Irritability, Headache, Bloating, Backache

20 Caplets

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Focus Consumer Healthcare, LLC, owner of

the registered trademark Maximum Strength

Pamprin® Multi-Symptom.

50844        REV0718B67909

QC

100%

SATISFACTION

GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-679
When Using This Product
  • drowsiness may occur
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of 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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

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

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • irritability
  • water-weight gain
Purpose

Pain reliever

Diuretic

Antihistamine

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.

Directions
  • do not take more than directed
  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC

QUALITY®

CHOICE

NDC 63868-961-20

Compare to the Active Ingredients

in Maximum Strength Pamprin®

Multi-Symptom*

Maximum Strength

Menstrual Pain Relief

Multi-Symptom

Acetaminophen - Pain Reliever

Pamabrom - Diuretic

Pyrilamine Maleate - Antihistamine

Relieves: Cramps, Irritability, Headache, Bloating, Backache

20 Caplets

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Focus Consumer Healthcare, LLC, owner of

the registered trademark Maximum Strength

Pamprin® Multi-Symptom.

50844        REV0718B67909

QC

100%

SATISFACTION

GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-679
When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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