Label: FAMOTIDINE- famotidine tablet, film coated

  • NDC Code(s): 69230-326-01, 69230-326-05, 69230-326-10, 69230-326-30, view more
    69230-326-60, 69230-327-01, 69230-327-05, 69230-327-10, 69230-327-30, 69230-327-50
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 11, 2022

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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 relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

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

    20 mg:

    • 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


    corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow.

  • Questions or comments?

    1-866-495-1995

  • PRINCIPAL DISPLAY PANEL


    Famotidine Tablets USP 10 mg - 30s container label
     

    famotab10mgcontlabel30s-count



    Famotidine Tablets USP 10 mg - 30s container carton label
       

    famotab10mgcontlabel30scontcarton


    Famotidine Tablets USP 10 mg - 10 (1x10) blister carton label
     

    famotab10mgcontlabel100scontcarton



    Famotidine Tablets USP 20 mg - 30s container label
     

    famotab20mgcontlabel-30scount



    Famotidine Tablets USP 20 mg - 30s container carton label


    famotab20mgcontlabel-30scontcarton



    Famotidine Tablets USP 20 mg - 10 (1x10) blister carton label

    famotab20mgcontlabel100s-contcarton

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE  
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-326
    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 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)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-326-301 in 1 CARTON11/08/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-326-601 in 1 CARTON11/08/2021
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-326-011 in 1 CARTON11/08/2021
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69230-326-051 in 1 CARTON11/08/2021
    4500 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69230-326-101 in 1 CARTON11/08/2021
    51000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21576611/08/2021
    FAMOTIDINE  
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-327
    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:69230-327-301 in 1 CARTON11/08/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-327-501 in 1 CARTON11/08/2021
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-327-011 in 1 CARTON11/08/2021
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69230-327-051 in 1 CARTON11/08/2021
    4500 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69230-327-101 in 1 CARTON11/08/2021
    51000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21576611/08/2021
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746analysis(69230-326, 69230-327) , manufacture(69230-326, 69230-327)
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