Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 49035-505-14, 49035-505-21, 49035-505-34, 49035-505-35, view more
    49035-505-39, 49035-505-80, 49035-505-95
  • Packager: Wal-Mart Stores, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 24, 2021

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  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active ingredient (in each tablet)

    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


    • 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 (1-800-222-1222) 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
    • keep the carton. It contains important information.
    • store at 20° to 25°C (68° to 77°F)
    • protect from moisture
  • Inactive ingredients


    carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide.

  • Questions or comments?


    1-888-287-1915

    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 vegetables
    • Eat slowly and avoid big meals
    • If overweight, lose weight
    • Quit smoking


    JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

    Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

    DISTRIBUTED BY: Wal-Mart Inc.,
    Bentonville, AR 72716
    MADE IN INDIA

    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Label)

    SEE NEW WARNINGS
    NDC 49035-505-35
    equateTM
    MAXIMUM STRENGTH
    Famotidine
    Tablets USP, 20 mg

    Acid Reducer
    • Just one tablet
    prevents and relieves
    heartburn due to
    acid Indigestion

    25
    TABLETS
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Label)


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Carton Label)

    SEE NEW WARNINGS
    NDC 49035-505-35

    equateTM

    Compare
    to Maximum
    Strength
    Pepcid® AC
    active
    ingredient*

    MAXIMUM STRENGTH
    Famotidine
    Tablets USP, 20 mg

    Acid Reducer

    • Just one tablet prevents
    and relieves heartburn due
    to acid indigestion

    Smaller tablet than the brand
    with the same effect 

    Actual Size

    20
    mg

    25
    TABLETS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Carton Label)


  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-505
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUND (Square shaped Biconvex) Size5mm
    FlavorImprint Code CC;59
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-505-351 in 1 CARTON04/26/2016
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49035-505-141 in 1 CARTON08/06/2020
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49035-505-211 in 1 CARTON08/06/2020
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:49035-505-341 in 1 CARTON08/06/2020
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:49035-505-952 in 1 CARTON08/06/2020
    550 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:49035-505-802 in 1 CARTON08/06/2020
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:49035-505-391 in 1 CARTON01/21/2021
    7365 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/26/2016
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(49035-505) , MANUFACTURE(49035-505)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(49035-505) , MANUFACTURE(49035-505)
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