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Pain Aid PMF (Zee Medical Inc)

Available Formats

Dosage Form Package Information Links
TABLET 50 CARTON in 1 CARTON (35418-710-68) > 125 PACKET in 1 CARTON (35418-710-67) > 2 TABLET in 1 PACKET (35418-710-02) Label Information

Complete Pain Aid PMF Information

  • 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:
    â–  water-weight gain â–  bloating
    â–  backache â–  headache â–  minor pain of menstrual and premenstrual cramps


  • DOSAGE & ADMINISTRATION

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

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    â–  more than 8 caplets in 24 hours, which is the maximum daily amount
    â–  with other drugs containing acetaminophen
    â–  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
    â–  pain lasts more than 10 days or gets worse
    â–  redness or swelling is present in the painful area
    â–  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 Type HUMAN OTC DRUG Item Code (Source) NDC:35418-710
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    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
    Color pink (rose pink) Score no score
    Shape CAPSULE (ZEE;PM) Size 18mm
    Flavor Imprint Code ZEE;PM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-710-68 50 in 1 CARTON
    1 NDC:35418-710-67 125 in 1 CARTON
    1 NDC:35418-710-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-710)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-710)