Label: ACID CONTROLLER- famotidine tablet, film coated

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

Drug Label Information

Updated June 14, 2022

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  • Active ingredient (in each tablet)

    Famotidine 20 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 10 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 20˚-25˚C (68˚-77˚F)
    •
    protect from moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose (monohydrate), magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, natural and artificial flavor, sucralose, titanium dioxide, triacetin

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Maximum Strength Pepcid® AC active ingredient

    H-E-B®

    Maximum Strength

    Acid Controller

    Famotidine Tablets, 20 mg

    Acid Reducer

    Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

    Cool Mint Flavor

    Releases a cooling sensation in mouth & throat

    actual size

    25 TABLETS

    Acid Controller Carton
  • INGREDIENTS AND APPEARANCE
    ACID CONTROLLER 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59640-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 32F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59640-001-631 in 1 CARTON06/06/2022
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735106/06/2022
    Labeler - H E B (007924756)
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