Label: FAMOTIDINE tablet

  • NDC Code(s): 64679-374-00, 64679-374-01, 64679-374-05, 64679-374-07, view more
    64679-374-08, 64679-374-09
  • 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 20 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.

    ●  if you have kidney disease, except under the advice and supervision of a 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 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

    ●  store at 20°-25°C (68°-77°F)

    ●  keep the carton. It contains important information.

    ●  protect from moisture

  • INACTIVE INGREDIENT

    Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and 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.130810

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Famotidine Tablets USP, 20 mg (OTC)

    20 mg – Acid reducer

    64679-374-05

    Label-20 mg
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-374
    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)  
    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)  
    Product Characteristics
    ColorWHITE (white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code W374
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-374-011 in 1 CARTON08/06/2010
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:64679-374-081 in 1 CARTON08/06/2010
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:64679-374-051 in 1 CARTON08/06/2010
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:64679-374-0710 in 1 CARTON08/06/2010
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:64679-374-0038000 in 1 DRUM; Type 0: Not a Combination Product08/06/2010
    6NDC:64679-374-096500 in 1 DRUM; Type 0: Not a Combination Product08/06/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09083708/06/2010
    Labeler - Wockhardt USA LLC. (170508365)
    Registrant - Wockhardt Limited (650069115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wockhardt Limited916489953ANALYSIS(64679-374) , LABEL(64679-374) , MANUFACTURE(64679-374) , PACK(64679-374)