Label: ACID REDUCER- famotidine tablet, film coated

  • NDC Code(s): 56062-141-65
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 31, 2022

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  • Active ingredient (in each tablet)

    Famotidine 10 mg

  • Purpose

    Acid reducer

  • 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

    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
    •
    kidney disease

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Acid reducers may interact with certain prescription drugs.

    Stop use and ask a doctor if

    •
    your heartburn continues or worsens
    •
    you need to take this product for more than 14 days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • 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 at any time from 15 to 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
  • Other information

    •
    read the directions and warnings before use
    •
    keep the carton. It contains important information.
    •
    store at 68°-77°F (20°-25°C)
    •
    protect from moisture
  • Inactive ingredients

    carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

  • Principal Display Panel

    FAMOTIDINE TABLETS, 10 mg

    acid reducer

    ORIGINAL STRENGTH

    ACTUAL SIZE

    • Just one tablet prevents and relieves heartburn due to acid indigestion

    30 TABLETS

    Compare to Pepcid® AC Original Strength active ingredient

    SEE NEW WARNINGS

    141-63-acid-reducer
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-141-6530 in 1 CARTON11/23/2009
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07540011/23/2009
    Labeler - Publix Super Markets Inc (006922009)
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