Home > Drugs A-Z > Famotidine

Famotidine (Amerisource Bergen)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 100 TABLET, FILM COATED in 1 BOTTLE (46122-168-78) Label Information

Complete Famotidine Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each tablet)

    Famotidine, USP 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
    • with other acid reducers
    • if you have kidney disease, except under the advice and supervision of a doctor
    • 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.

    Ask a doctor before use if you have
    • frequent chest pain
    • stomach pain
    • unexplained weight loss
    • nausea or vomiting
    • frequent wheezing, particularly with heartburn
    • 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

    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

    • store at 20° to 25° C (68° to 77° F)
    • protect from moisture
    • read the directions and warnings before use

  • Inactive ingredients

    colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide


  • Questions?

    call 1-800-406-7984


  • SPL UNCLASSIFIED SECTION

    Distributed By: AmerisourceBergen 1300 Morris Drive Chesterbrook, PA 19087


  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

    GOOD
    NEIGHBOR
    PHARMACY®

    NDC 46122-0168-78

    †Compare to the active ingredient of
    Maximum Strength Pepcid AC®

    famotidine tablets, USP 20 mg

    Acid Reducer

    Maximum Strength

    Just One Tablet
    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    100 tablets

    PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-168
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 036
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-168-78 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090283 05/01/2013
    Labeler - AMERISOURCE BERGEN (007914906)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 MANUFACTURE(46122-168)