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Famotidine (Dr.Reddys Laboratories Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 CARTON (55111-118-90) > 90 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-118-30) > 30 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-118-18) > 180 TABLET in 1 BOTTLE Label Information
TABLET 3 BLISTER PACK in 1 CARTON (55111-118-81) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-118-60) > 60 TABLET in 1 BOTTLE Label Information
TABLET 4 BLISTER PACK in 1 CARTON (55111-118-24) > 6 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BLISTER PACK in 1 CARTON (55111-118-79) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 3 BLISTER PACK in 1 CARTON (55111-118-35) > 6 TABLET in 1 BLISTER PACK Label Information

Complete Famotidine Information

  • Active ingredient (in each tablet)

    Famotidine USP, 10 mg/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 (for Famotidine 20 mg)
    • 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

    • For Famotidine 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 at any time from 15 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
    • For Famotidine 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

  • Other information

    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • store at 20°-25°C (68°-77°F) [See USP controlled Room Temperature]
    • protect from moisture and light

  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide


  • Questions or comments?

    Call 1-888-375-3784


  • SPL UNCLASSIFIED SECTION

    Tips for Managing Heartburn

    • Do not lie flat or bend over after eating
    • Do not wear tight-fitting clothing around the stomach
    • Do not eat before bedtime
    • Raise the head of your bed
    • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
    • Eat slowly and avoid big meals
    • If overweight, lose weight
    • Quit smoking

  • PRINCIPAL DISPLAY PANEL

    Famotidine 10 mg

    Container Label

    container10mg


  • SPL UNCLASSIFIED SECTION

    Container Carton Label

    carton10mg


  • PRINCIPAL DISPLAY PANEL

    Famotidine 20 mg

    Container Label

    container20mg


  • SPL UNCLASSIFIED SECTION

    Container Carton Label

    carton20mg


  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-118
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code C;118
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-118-30 1 in 1 CARTON
    1 30 in 1 BOTTLE
    2 NDC:55111-118-60 1 in 1 CARTON
    2 60 in 1 BOTTLE
    3 NDC:55111-118-90 1 in 1 CARTON
    3 90 in 1 BOTTLE
    4 NDC:55111-118-18 1 in 1 CARTON
    4 180 in 1 BOTTLE
    5 NDC:55111-118-24 4 in 1 CARTON
    5 6 in 1 BLISTER PACK
    6 NDC:55111-118-35 3 in 1 CARTON
    6 6 in 1 BLISTER PACK
    7 NDC:55111-118-81 3 in 1 CARTON
    7 10 in 1 BLISTER PACK
    8 NDC:55111-118-79 1 in 1 CARTON
    8 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077367 09/30/2006
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-396
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code L1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-396-50 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:55111-396-44 2 in 1 CARTON
    2 NDC:55111-396-01 100 in 1 BOTTLE
    3 NDC:55111-396-32 1 in 1 CARTON
    3 170 in 1 BOTTLE
    4 NDC:55111-396-08 1 in 1 CARTON
    4 8 in 1 BLISTER PACK
    5 NDC:55111-396-16 5 in 1 CARTON
    5 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077367 09/30/2006
    Labeler - Dr.Reddys Laboratories Limited (650562841)
    Establishment
    Name Address ID/FEI Business Operations
    Dr.Reddys Laboratories Limited 918608162 analysis, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Reed Lane Inc 001819879 pack
    Establishment
    Name Address ID/FEI Business Operations
    Dr. Reddy's Laboratories Louisiana LLC 830397282 analysis