FAMOTIDINE TABLET [WOCKHARDT LIMITED]

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FAMOTIDINE TABLET [WOCKHARDT LIMITED]
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NDC 55648-374-00, 55648-374-01, 55648-374-05, 55648-374-07, 55648-374-08, 55648-374-09
Set ID fdff466f-9884-4bbd-89af-0e186a54801b
Category HUMAN OTC DRUG LABEL
Packager WOCKHARDT LIMITED
Generic Name
Product Class
Product Number
Application Number ANDA090837
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  • 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
  • PRINCIPAL DISPLAY PANEL

    Famotidine 20 mg_OTC_500's Bottle Label

    Famotidine 20 mg_OTC_500's Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-374
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (white) Scoreno score
    ShapeROUND (barrel shaped) Size9mm
    FlavorImprint Code W374
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55648-374-011 in 1 CARTON
    130 in 1 BOTTLE
    2NDC:55648-374-081 in 1 CARTON
    230 in 1 BOTTLE
    3NDC:55648-374-051 in 1 CARTON
    3500 in 1 BOTTLE
    4NDC:55648-374-0710 in 1 CARTON
    410 in 1 BLISTER PACK
    5NDC:55648-374-0038000 in 1 DRUM
    6NDC:55648-374-096500 in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09083708/06/2010
    Labeler - WOCKHARDT LIMITED (650069115)
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