Label: FAMOTIDINE tablet

  • NDC Code(s): 64679-972-00, 64679-972-01, 64679-972-02, 64679-972-03
  • Packager: Wockhardt USA LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 26, 2019

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

  • OTC - ACTIVE INGREDIENT SECTION

    Famotidine USP 10 mg

  • OTC - PURPOSE SECTION

    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

    Stop use and ask a doctor if

    ●   your heartburn continues or worsens

    ●   you need to take this product for more than 14 days

    PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    ●  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

  • OTHER INFORMATION

    ●  read the directions and warnings before use

    ●  store at 25°-30°C (77°-86°F)

    ●  protect from moisture

    ●  keep the carton and package insert. They contain important information.

  • INACTIVE INGREDIENT

    hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide.

  • QUESTIONS OR COMMENTS

    Call 1-800-346-6854

    Manufactured by:

    Wockhardt Limited,

    Mumbai, India.

    Distributed by:

    Wockhardt USA LLC.

    20 Waterview Blvd.

    Parsippany, NJ 07054

    USA.

    Iss.100510

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Famotidine Tablets USP, 10 mg (OTC)

    10 mg – Acid reducer

    64679-972-03

    Label
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-972
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINK (pink) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code W;972
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-972-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2005
    2NDC:64679-972-0210 in 1 CARTON03/07/2005
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:64679-972-0050000 in 1 DRUM; Type 0: Not a Combination Product03/07/2005
    4NDC:64679-972-0340000 in 1 DRUM; Type 0: Not a Combination Product03/07/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07714603/07/2005
    Labeler - Wockhardt USA LLC. (170508365)
    Registrant - Wockhardt Limited (650069115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wockhardt Limited916489953ANALYSIS(64679-972) , LABEL(64679-972) , MANUFACTURE(64679-972) , PACK(64679-972)