Label: MENSTRUAL PAIN RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 10, 2021

If you are a consumer or patient please visit this version.

  • 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 of 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 (1-800-222-1222) 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

    Rite
    Aid®
    PHARMACY

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

    MAXIMUM STRENGTH
    menstrual pain relief

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


    MULTI-SYMPTOM RELIEF OF:
    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       REV0718B67910

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

    Rite Aid 44-679

    Rite Aid 44-679


  • INGREDIENTS AND APPEARANCE
    MENSTRUAL PAIN RELIEF  MAXIMUM STRENGTH
    acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;679
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6790-41 in 1 CARTON01/03/2015
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/03/2015
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-6790)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(11822-6790)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-6790)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(11822-6790)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11822-6790)