Label: ACID REDUCER MAXIMUM STRENGTH- famotodine tablet

  • NDC Code(s): 69168-445-32, 69168-445-52
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 30, 2024

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  • Active ingredient(s)

    Famotidine USP 20 mg

  • Purpose

    Acid reducer

  • Use(s)

    • 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 
    • explained 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 breastfeeding,

    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
    • do not use if imprinted safety seal under cap is broken or
      missing n store at 20°-25°C (68°-77°F)
    • protect from moisture
  • Inactive ingredients

    carnauba wax, corn starch, hydroxypropyl cellulose,
    hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline
    cellulose, sodium starch glycolate, talc, titanium dioxide

  • Questions/Comments

    Call 1-888-952-0050 Monday through Friday
    9AM − 5PM EST

  • Principal Display Panel

    Acid Reducer

    Acid Reducer

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER  MAXIMUM STRENGTH
    famotodine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-445
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-445-32100 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    2NDC:69168-445-52225 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21576710/31/2024
    Labeler - Allegiant Health (079501930)
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