Label: FAMOTIDINE tablet, film coated

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

Drug Label Information

Updated April 12, 2024

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  • SPL UNCLASSIFIED SECTION

    20 mg

    For Hospital Use Only

    Drug Facts

  • 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

    • Use as directed per healthcare professional.
    • 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
    • store at 20°-25°C (68°-77°F)
    • protect from moisture
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

  • Questions or comments?

    1-800-397-9228

  • SPL UNCLASSIFIED SECTION

    GLUTEN FREE

  • How Supplied

    NDC 68094-054-65
    Unit Dose Packages of 200 Tablets
    (20 × 10) per Carton

  • SPL UNCLASSIFIED SECTION

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    For inquiries call Precision Dose, Inc.
    at 1-800-397-9228 or email
    druginfo@precisiondose.com

    LI1465 Rev. 08/23

  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label

    Precision Dose™

    NDC 68094-054-65
    Unit Dose

    Famotidine
    Tablets 20 mg

    200 Tablets
    (20 x 10)
    (in each tablet)
    Famotidine 20 mg
    Acid reducer

    Directions
    To relieve symptoms, swallow 1 tablet
    with a glass of water. Do not chew.

    GLUTEN FREE

    USUAL DOSE: SEE ENCLOSED DRUG FACTS

    Store at 20°-25°C (68°-77°F)
    protect from moisture

    Keep out of reach of children.
    Hospital Use Only.

    LC1464
    R1

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-054(NDC:0113-0194)
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-054-6520 in 1 CARTON03/28/2024
    1NDC:68094-054-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735103/28/2024
    Labeler - Precision Dose, Inc. (035886746)
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