Label: FAMOTIDINE- famotidine tablet, film coated

  • NDC Code(s): 83324-003-30, 83324-008-50
  • Packager: CHAIN DRUG MARKETING ASSOCIATION, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 27, 2024

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  • 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:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.

    10 mg:
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn

    20 mg:

    • to preventsymptoms, swallow 1 tablet 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° to 25°C (68° to 77°F)
    • protect from moisture

  • Inactive ingredients


    10 mg:
    carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.

    20 mg:

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

  • Questions or comments?


    1-888-375-3784
    JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
    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




    Distributed by CDMA, Inc.
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

  • PRINCIPAL DISPLAY PANEL


    Famotidine Tablets USP 10 mg - 30s container label
       

    famotidinetablets10mg30scountcontainer



    Famotidine Tablets USP 10 mg - 30s container carton label
       

    amotidinetablets10mg30scountcarton

    Famotidine Tablets USP 20 mg - 50s container label
      

    famotidinetablets20mg50scountcontainer

    Famotidine Tablets USP 20 mg - 50s container carton label  

    famotidinetablets20mg50scountcarton

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE  
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-003-301 in 1 CARTON03/06/2024
    130 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21576603/06/2024
    FAMOTIDINE  
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-008
    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 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Coloryellow (Light yellow) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-008-501 in 1 CARTON03/06/2024
    150 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21576603/06/2024
    Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746analysis(83324-003, 83324-008) , manufacture(83324-003, 83324-008)
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