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FAMOTIDINE (WOCKHARDT USA LLC.)

Available Formats

Dosage Form Package Information Links
TABLET 10 BLISTER PACK in 1 CARTON (64679-374-07) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 38000 TABLET in 1 DRUM (64679-374-00) Label Information
TABLET 1 BOTTLE in 1 CARTON (64679-374-08) > 30 TABLET in 1 BOTTLE Label Information
TABLET 6500 TABLET in 1 DRUM (64679-374-09) Label Information
TABLET 1 BOTTLE in 1 CARTON (64679-374-05) > 500 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (64679-374-01) > 30 TABLET in 1 BOTTLE Label Information

Complete FAMOTIDINE Information

  • SPL UNCLASSIFIED SECTION


    Drugs Facts


  • Active ingredient (in each tablets)

    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
    • 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.
    • if you have kidney disease, except under the advice and supervision of a 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.

  • 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
    • store at 20°-25°C (68°-77°F)
    • keep the carton. It contains important information.
    • protect from moisture

  • Inactive ingredients

    Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.
  • Questions or comments?

    Call 1-800-346-6854

    Manufactured by:
    Wockhardt Limited,
    Mumbai, India.

    Distributed by:
    Wockhardt USA LLC.
    20 Waterview Blvd.
    Parsippany, NJ 07054
    USA.

    Iss.130810

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-374
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (barrel shaped) Size 9mm
    Flavor Imprint Code W374
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64679-374-01 1 in 1 CARTON
    1 30 in 1 BOTTLE
    2 NDC:64679-374-08 1 in 1 CARTON
    2 30 in 1 BOTTLE
    3 NDC:64679-374-05 1 in 1 CARTON
    3 500 in 1 BOTTLE
    4 NDC:64679-374-07 10 in 1 CARTON
    4 10 in 1 BLISTER PACK
    5 NDC:64679-374-00 38000 in 1 DRUM
    6 NDC:64679-374-09 6500 in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090837 08/06/2010
    Labeler - WOCKHARDT USA LLC. (170508365)