PAIN AID PMF (ACETAMINOPHEN, PAMABROM) TABLET [ZEE MEDICAL INC]

PAIN AID PMF (ACETAMINOPHEN, PAMABROM) TABLET [ZEE MEDICAL INC]
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NDC 35418-710-02, 35418-710-67, 35418-710-68
Set ID a5d0dce4-ee28-4849-8a1f-06600e8d5d95
Category HUMAN OTC DRUG LABEL
Packager Zee Medical Inc
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)  Acetaminophen 500mg, Pamabrom 25 mg

  • PURPOSE

    Purpose-Pain Reliever, Diuretic

  • INDICATIONS & USAGE

    Uses
    temporarily relieves the following menstrual and premenstrual symptoms:
    ■ water-weight gain ■ bloating
    ■ backache ■ headache ■ minor pain of menstrual and premenstrual cramps

  • DOSAGE & ADMINISTRATION

    Directions

    • adults: take 2 tablets every 6 hours, not more than 8 tablets in 24 hours
    • children under 12 years: ask a doctor
  • WARNINGS

    Warnings
    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
    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
    Stop use and ask a doctor if
    ■ pain lasts more than 10 days or gets worse
    ■ redness or swelling is present in the painful area
    ■ any new symptoms appear

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. 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.

  • INACTIVE INGREDIENT

    Inactive ingredients
    croscarmellose sodium, crospovidone, FDC red 40 aluminum lake, hydroxypropyl methylcellulose, maltodextrin*, magnesium
    stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, povidone, sodium starch glycolate*, starch, stearic acid,
    titanium dioxide
    *contains one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    MM1PMF 250 Box 1

  • INGREDIENTS AND APPEARANCE
    PAIN AID PMF 
    acetaminophen, pamabrom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-710
    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
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorpink (rose pink) Scoreno score
    ShapeCAPSULE (ZEE;PM) Size18mm
    FlavorImprint Code ZEE;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-710-6850 in 1 CARTON06/12/2012
    1NDC:35418-710-67125 in 1 CARTON
    1NDC:35418-710-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(35418-710)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004repack(35418-710)

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