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

  • NDC Code(s): 83324-057-20
  • Packager: Chain Drug Marketing Association, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 17, 2024

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

View All Sections
  • 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

    • 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.

    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

    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

    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

    Quality Choice 44-679

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL PAIN RELIEF 
    acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-057
    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 ALUMINUM LAKE (UNII: 6T47AS764T)  
    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:83324-057-201 in 1 CARTON06/21/2024
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/21/2024
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(83324-057)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(83324-057)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(83324-057)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(83324-057)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(83324-057)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!