OTC Medication Information: Menstrual Pain Relief Maximum Strength

MENSTRUAL PAIN RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom and pyrilamine maleate tablet, film coated
Rite Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

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.

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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
  • 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.

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

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

Compare to the active ingredients in Maximum Strength Pamprin® Multi-Symptom*

NDC 11822-679-4

MAXIMUM STRENGTH
Menstrual Pain Relief

ACETAMINOPHEN , PAMABROM, PYRILAMINE MALEATE
Pain Reliever • Diuretic • Antihistamine


MULTI-SYMPTOM RELIEF
of Cramps, Bloating, Irritability, Headache & Backache

Aspirin Free
Caffeine Free

ACTUAL SIZE

40
CAPLETS

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 REV0718C67910

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011www.riteaid.com

Rite Aid 44-679
(click image for full-size original)

Rite Aid 44-679

MENSTRUAL PAIN RELIEF MAXIMUM STRENGTH acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6790
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM 25 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SHELLAC
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color purple Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;679
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-6790-4 1 BOTTLE in 1 CARTON contains a BOTTLE
1 40 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (11822-6790-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/03/2015
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (11822-6790)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (11822-6790)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (11822-6790)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (11822-6790)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (11822-6790)

Revised: 08/2022 Rite Aid Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.