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Famotidine (Ipca Laboratories Limited)

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TABLET 10000 TABLET in 1 POUCH (57451-5065-1) Label Information

Complete Famotidine Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts:


  • Active ingredient ( in each tablet)

    For 10 mg:

    Famotidine USP, 10 mg

    For 20 mg :

    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

    • For 10 mg:
    • with other acid reducers
    • 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.
    • For 20 mg:
    • with other acid reducers
    • 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

  • Ask a doctor before use if you have

    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
    • 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

    For 10 mg:

    • 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 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

    For 20 mg

    • 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

  • SPL UNCLASSIFIED SECTION

    Other information

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

  • Inactive ingredients

    For 10 mg: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, talc, ferric iron oxide.

    For 20 mg: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, talc.


  • Questions?

    Call 1-800-406-7984


  • SPL UNCLASSIFIED SECTION

    • 1 tablet relieves heartburn due to acid indigestion
    • Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
    Tips for Managing Heartburn
    â– Do not lie flat or bend over after eating
    â– Do not wear tight fitting clothing around the stomach
    â– Do not eat before bedtime
    â– Raise the head of your bed
    â– Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetablets.
    â– Eat slowly and avoid big meals
    â– If overweight, lose weight
    â– Quit smoking

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Ohm Laboratories Inc.

    14 Terminal Road

    New Brunswick, NJ 08901

    Manufactured by:    

    Ipca Laboratories Limited

    1, Pharma Zone, SEZ Indore,

    Pithampur 454775, (M.P.), India


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Ohm Laboratories Inc.\Ranbaxy Group Company

    NDC: 57451-5065-1

    Famotidine Tablets USP 10 mg

    1x 10000 Tablets

    Each tablet contains:

    Famotidine USP 10 mg

    Store between 20° to 25°C (68° to 77°F)

    Code                       :  MP/DRUGS/25/1/2008

    Batch No.           :

    Mfg. Dt.           :

    Exp. Dt.           :

    Manufactured for:

    Ohm Laboratories Inc.

    14 Terminal Road

    New Brunswick, NJ 08901

    Manufactured by:

    Ipca Laboratories Limited

    1, Pharma Zone, SEZ, Indore

    Pithampur- 454775 (M.P.), India

    10-mg

    Ohm Laboratories Inc.\Ranbaxy Group Company

    NDC: 57451-5066-1

    Famotidine Tablets USP 20 mg

    1x 10000 Tablets

    Each tablet contains:

    Famotidine USP 20 mg

    Store between 20° to 25°C (68° to 77°F)

    Code                       :  MP/DRUGS/25/1/2008

    Batch No.           :

    Mfg. Dt.           :

    Exp. Dt.           :

    Manufactured for:

    Ohm Laboratories Inc.

    14 Terminal Road

    New Brunswick, NJ 08901

    Manufactured by:

    Ipca Laboratories Limited

    1, Pharma Zone, SEZ, Indore

    Pithampur- 454775 (M.P.), India

    20-mg

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57451-5065
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 035
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57451-5065-1 10000 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090283 06/25/2010
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57451-5066
    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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    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:57451-5066-1 10000 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090283 07/23/2010
    Labeler - Ipca Laboratories Limited (862179827)
    Registrant - Ipca Laboratories Limited (650387009)
    Establishment
    Name Address ID/FEI Business Operations
    Ipca Laboratories Limited 677600550 Manufacture