Label: FEMADRINE- acetaminophen, pamabrom tablet

  • 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 November 28, 2016

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  • ACTIVE INGREDIENT

    Acetaminophen 325mg

    Pamabrom 25mg

  • PURPOSE

    Pain reliever, Diuretic

  • INDICATIONS & USAGE

    Uses: For the relief of:

    • cramps • bloating • water-weight gain

    • headaches • backaches • muscular aches and pains

  • WARNINGS

    Warnings:

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours

    • with any other drugs containing acetaminophen (prescription or non-prescription).

    • 3 or more alcoholic drinks a while using this product.

  • ASK DOCTOR/PHARMACIST

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • OVERDOSAGE

    In case of 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.

  • DOSAGE & ADMINISTRATION

    Directions: Do not use more than directed.

    Adults and children: (12 years and older) Take 2 tablets with water. Repeat every 4 hours, as needed, not to exceed 8 tablets in any 24 hour period.

    Children under 12 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

  • PRINCIPAL DISPLAY PANEL

    AfasscoFemadrine12-16

  • INGREDIENTS AND APPEARANCE
    FEMADRINE 
    acetaminophen, pamabrom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    Product Characteristics
    Colorwhite (with red and green crystals) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-0700-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/25/2016
    Labeler - Afassco Inc. (609982723)
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