Label: HEARTBURN RELIEF- famotidine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 14, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Famotidine USP 10mg


  • PURPOSE

    Acid Reducer

  • DOSAGE & ADMINISTRATION

    Directions • adults and

    children 12 years and over: • to relieve symptoms,

    swallow 1 tablet with a glass of water. Do not chew.

    • to prevent symptoms, swallow 1 tablet with a

    glass of water 60 minutes before eating food or

    drinking beverages that cause heartburn • do not

    use more than 2 tablets in 24 hours • children under

    12 years: ask a doctor

  • INDICATIONS & USAGE

    Uses: • relieves heartburn associated with acid

    indigestion and sour stomach • prevents heartburn

    associated with acid indigestion and sour stomach

    brought on by eating or drinking certain food and

    beverages

  • WARNINGS

    Warnings: Allergy alert: Do not use if

    you are allergic to famotidine or other acid reducers

    Do not use • if you have trouble or pain swallowing

    food, vomiting with blood, or bloody or black stools.

    These may be signs of a serious condition. See your

    doctor. • with other acid reducers Ask a doctor

    before use if you have • had heartburn over 3

    months. This may be a sign of a more serious

    condition. • heartburn with lightheadedness,

    sweating, or dizziness • chest pain or shoulder

    pain with shortness of breath; sweating; pain

    spreading to arms, neck or shoulders; or

    lightheadedness • frequent chest pain • frequent

    wheezing particularly with heartburn • unexplained

    weight loss • nausea or vomiting • stomach pain

    Stop use and ask a doctor if • your

    heartburn continues or worsens • you

    need to take this product for more than

    14 days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    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.

  • INACTIVE INGREDIENT

    Inactive ingredients hydroxypropyl

    cellulose, hypromellose, iron oxide red, magnesium

    stearate, microcrystalline cellulose, polyethylene

    glycol 400, pregelatinized starch, talc, titanium

    dioxide

  • PRINCIPAL DISPLAY PANEL

    Heartburn ReliefMM1


  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF  
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-448
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Colorpink (ROSE PINK) Scoreno score
    ShapeROUND (W972) Size8mm
    FlavorImprint Code W972
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-448-011 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07714603/14/2014
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)