Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 72657-112-20, 72657-112-90, 72657-113-20, 72657-113-88
  • Packager: GLENMARK THERAPEUTICS INC., USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 9, 2022

If you are a consumer or patient please visit this version.

  • 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 are taking 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:
    o
    to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    o
    to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    o
    to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    o
    before eating food or drinking beverages that cause heartburn
    o
    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°C to 25°C (68°F to 77°F)
    protect from moisture
  • Inactive ingredients

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

  • Questions or comments?

    Call us at 1 (888) 721-7115 (toll-free)

  • SPL UNCLASSIFIED SECTION

    Distributed by: Glenmark Therapeutics Inc., USA
    Mahwah, NJ 07430
    Made in India
    M.L. No.: 02/SKL/AP/2015/F/R

    Revision: 04/22

  • Principal Display Panel

    NDC 72657-112-90

    Famotidine Tablets, USP 10mg

    90 Tablets

    carton10mg90
  • Principal Display Panel

    NDC 72657-113-88

    Famotidine Tablets, USP 20mg

    85 Tablets

    carton20mg85
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-112
    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:72657-112-901 in 1 CARTON06/01/2022
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:72657-112-201 in 1 CARTON06/01/2022
    2200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21582206/01/2022
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-113
    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:72657-113-881 in 1 CARTON06/01/2022
    185 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:72657-113-201 in 1 CARTON06/01/2022
    2200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21582206/01/2022
    Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
    Establishment
    NameAddressID/FEIBusiness Operations
    VKT Pharma Private Limited871408062MANUFACTURE(72657-112, 72657-113)