Label: PAMPRIN MULTI-SYMPTOM MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet

  • NDC Code(s): 71687-3003-1, 71687-3003-4
  • Packager: Focus Consumer Healthcare, LLC
  • 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, 2020

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  • Drug Facts

    Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Pamabrom 25 mg
    Pyrilamine maleate 15 mg

  • PURPOSE

    Purposes

    Pain reliever
    Diuretic
    Antihistamine

  • INDICATIONS & USAGE

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

    • cramps

    • headache

    • bloating

    • backache
    • water-weight gain

    • muscular aches

    • irritability

  • WARNINGS

    Allergy warning: 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.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product


    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.

    Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers

    When using this product • you may get drowsy, avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving or operating machinery • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breast-feeding, ask a health professional before use.

    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.

  • Directions

    adults and children 12 years and over:

    • take 2 caplets with water every 6 hours as needed

    • do not exceed 8 caplets in a 24 hour period or as directed by a doctor

    • do not use more than directed (see warnings)

    children under 12 years: ask a doctor

  • INACTIVE INGREDIENT

    blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or Comments?

    www.pamprin.com

  • SPL UNCLASSIFIED SECTION

    IF IMPRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.

    Easy-open bottle with child-resisitant packaging. Purchase only if carton end flaps are sealed.

    Distributed by:

    Focus Consumer Healthcare, LLC

    801 Broad Street, Chattanooga, TN 37402

    Made in Canada

    ©2017 Focus Consumer Healthcare, LLC

    www.pamprin.com

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    Pamprin Multi-Symptom

    for complete Relief of • Cramps •Headache •Backache •Irritability •Bloating

    Mentrual Pain Relief

    Aspirin-free and Caffeine-free with Acetaminophen, Pamabrom and Pyrilamine Maleate

    20 Caplets

    Label-focus

    Label-focus-2

  • INGREDIENTS AND APPEARANCE
    PAMPRIN MULTI-SYMPTOM  MAXIMUM STRENGTH
    acetaminophen, pamabrom, pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-3003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71687-3003-11 in 1 CARTON06/01/2016
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:71687-3003-41 in 1 CARTON06/01/2016
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2016
    Labeler - Focus Consumer Healthcare, LLC (080743737)
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