Label: PAIN AID PMF - acetaminophen and pamabrom tablet 

  • Label RSS
  • NDC Code(s): 35418-710-02, 35418-710-67, 35418-710-68
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

    Close
  • PURPOSE

    Purpose-Pain Reliever, Diuretic

    Close
  • INDICATIONS & USAGE

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

    Close
  • DOSAGE & ADMINISTRATION

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

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • 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

    Close
  • PRINCIPAL DISPLAY PANEL

    MM1PMF 250 Box 1

    Close
  • INGREDIENTS AND APPEARANCE
    PAIN AID PMF 
    acetaminophen, pamabrom tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-710
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    PAMABROM (BROMOTHEOPHYLLINE) PAMABROM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 3350  
    POLYSORBATE 80  
    POVIDONE K29/32  
    TITANIUM DIOXIDE  
    STEARIC ACID  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    FD&C RED NO. 40  
    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)
    Close