FAMOTIDINE TABLET [IPCA LABORATORIES LIMITED]

FAMOTIDINE TABLET [IPCA LABORATORIES LIMITED]
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NDC 57451-5065-1, 57451-5066-1
Set ID d80b4d0c-650d-454a-b5d7-d6fee102e783
Category HUMAN OTC DRUG LABEL
Packager Ipca Laboratories Limited
Generic Name
Product Class
Product Number
Application Number ANDA090283
  • 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
    ■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 vegetablets.
    ■Eat slowly and avoid big meals
    ■If overweight, lose weight
    ■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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5065
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 035
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57451-5065-110000 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028306/25/2010
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5066
    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, 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
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57451-5066-110000 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028307/23/2010
    Labeler - Ipca Laboratories Limited (862179827)
    Registrant - Ipca Laboratories Limited (650387009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ipca Laboratories Limited677600550Manufacture

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