Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 71821-010-12, 71821-012-08
  • Packager: VKT Pharma Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Famotidine USP, 10 mg and 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.
    • 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
    • kidney disease

    Ask a doctor or pharmacist before use if you aretaking a prescription drug. Acid reducers may interact with certain prescription drugs.

    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

    • adults and children 12 years and over:
      • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
      • to preventsymptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn
      • to preventsymptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes beforeeating 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)
    • protect from moisture
    • compares to the active ingredient in Zantac 360
  • Inactive ingredients

    Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

  • Questions or comments?

    1 844-387-1231 (toll-free)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    VKT Pharma Private Limited
    Srikakulam, India-532 409,
    M.L. No.: 02/SKL/AP/2015/F/R

    Repackaged  by:
    Granules USA Inc,
    35 Waterview Blvd, 3rd Floor
    Parsippany NJ 07054 USA.

    Revision: 08/2022

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Famotidine Tablets USP 10mg - NDC 71821-012-08 -Container Label

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    Famotidine Tablets USP 10mg - NDC 71821-012-08 -Pouch Label

    image description

    Famotidine Tablets USP 20mg - NDC 71821-010-12 -Container Label

    image description

    Famotidine Tablets USP 20mg - NDC 71821-010-12 -Pouch Label

    image description
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71821-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code V;21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71821-012-08288461 in 1 BAG; Type 0: Not a Combination Product09/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21582201/28/2022
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71821-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code V;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71821-010-12144230 in 1 BAG; Type 0: Not a Combination Product09/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21582201/28/2022
    Labeler - VKT Pharma Private Limited (871408062)
    Registrant - VKT Pharma Private Limited (871408062)
    Establishment
    NameAddressID/FEIBusiness Operations
    VKT Pharma Private Limited871408062manufacture(71821-012, 71821-010)
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