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FAMOTIDINE (WOCKHARDT USA LLC.)

Available Formats

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

Complete FAMOTIDINE Information

  • OTC - ACTIVE INGREDIENT SECTION

    Famotidine USP 20 mg


  • OTC - PURPOSE SECTION

    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

    PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

     


  • OTC - 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 INGREDIENT

    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


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Famotidine Tablets USP, 20 mg (OTC)

    20 mg – Acid reducer

    64679-374-05

    Label-20 mg

  • 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)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (white) Score no score
    Shape ROUND 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 08/06/2010
    1 30 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:64679-374-08 1 in 1 CARTON 08/06/2010
    2 30 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:64679-374-05 1 in 1 CARTON 08/06/2010
    3 500 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:64679-374-07 10 in 1 CARTON 08/06/2010
    4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:64679-374-00 38000 in 1 DRUM; Type 0: Not a Combination Product 08/06/2010
    6 NDC:64679-374-09 6500 in 1 DRUM; Type 0: Not a Combination Product 08/06/2010
    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)
    Registrant - Wockhardt Limited (650069115)
    Establishment
    Name Address ID/FEI Business Operations
    Wockhardt Limited 916489953 ANALYSIS(64679-374) , LABEL(64679-374) , MANUFACTURE(64679-374) , PACK(64679-374)