Label: ACID CONTROLLER ORIGINAL STRENGTH- famotidine tablet

  • NDC Code(s): 59779-141-39, 59779-141-60, 59779-141-72, 59779-141-75
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 20, 2019

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

  • 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

    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 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 20°-25°C (68°-77°F)
    protect from moisture and light
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Original Strength Pepcid® AC

    Original Strength

    Acid Controller

    FAMOTIDINE TABLETS, 10 mg

    Acid Reducer

    Just one tablet:

    Prevents & relieves heartburn due to acid indigestion

    Actual Size

    30 TABLETS

    Acid Controller Carton
  • INGREDIENTS AND APPEARANCE
    ACID CONTROLLER  ORIGINAL STRENGTH
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-141
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:59779-141-602 in 1 CARTON12/03/2009
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59779-141-721 in 1 CARTON02/19/2010
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-141-751 in 1 CARTON10/17/2009
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59779-141-391 in 1 CARTON09/24/2015
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07540010/17/2009
    Labeler - CVS Pharmacy (062312574)