FEMADRINE (ACETAMINOPHEN, PAMABROM) TABLET [AFASSCO INC.]

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FEMADRINE (ACETAMINOPHEN, PAMABROM) TABLET [AFASSCO INC.]
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NDC 51532-0700-2
Set ID 326f1c99-15d4-40c5-b356-8bad252b3319
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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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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