Label: FAMOTIDINE 10 MG tablet, coated
FAMOTIDINE 20 MG tablet, coated

  • NDC Code(s): 25000-086-03, 25000-086-07, 25000-086-08, 25000-086-36, view more
    25000-087-03, 25000-087-05, 25000-087-08, 25000-087-36, 25000-087-82
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 23, 2024

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

  • Active ingredient (in each tablet)

    For 10 mg:

    Famotidine USP 10 mg


    For 20 mg:

    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 right away. (1-800-222-1222)

  • Directions

    For 10mg:

    • adults and children 12 years and over:
    o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    o 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
    o do not use more than 2 tablets in 24 hours
    • children under 12 years: ask a doctor


    For 20 mg:

    • adults and children 12 years and over:
    o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    o 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
    o 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°-25°C (68°-77°F)
    • protect from moisture
    • FDA approved dissolution test specifications differ from USP



  • Inactive ingredients

    For 10 mg:

    carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide


    For 20 mg:

    carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

  • Questions or comments?

    Call 1-877-376-4271 (weekdays 9 AM to 5 PM)


    • 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



    Manufactured for:
    Time-Cap Labs, Inc.
    7 Michael Avenue,
    Farmingdale,
    NY 11735, USA


    Manufactured by:
    Marksans Pharma Ltd.
    Plot No. L-82, L-83
    Verna Indl. Estate
    Verna, Goa-403722, India 

  • PRINCIPAL DISPLAY PANEL

    Famotidine Tablets USP, 10 mg


    NDC: 25000-086-36

    Famotidine Tablets USP 10 mg

    30's (3 x 10's blister) count Carton Label


    famo-10-mg-blister-ifc-3x10s


    NDC: 25000-086-03

    Famotidine Tablets USP 10 mg

    30's count Bottle Label


    famo-10mg-label-30s


    NDC: 25000-086-03

    Famotidine Tablets USP 10 mg

    30's count Carton Label


    famo-10mg-ifc-30s


    NDC: 25000-086-08

    Famotidine Tablets USP 10 mg

    100's count Bottle Label


    famo-10mg-label-100s


    NDC: 25000-086-08

    Famotidine Tablets USP 10 mg

    100's count Carton Label


    famo-10mg-ifc-100s


    Famotidine Tablets USP, 20 mg


    NDC: 25000-087-36

    Famotidine Tablets USP 20 mg

    30's (3 x 10's blister) count Carton Label


    famo-20-mg-blister-ifc-3x10s


    NDC: 25000-087-03

    Famotidine Tablets USP 20 mg

    30's count Bottle Label


    famo-20mg-label-30s


    NDC: 25000-087-03

    Famotidine Tablets USP 20 mg

    30's count Carton Label


    famo-20mg-ifc-30s


    NDC: 25000-087-08

    Famotidine Tablets USP 20 mg

    100's count Bottle Label


    famo-20mg-label-100s


    NDC: 25000-087-08

    Famotidine Tablets USP 20 mg

    100's count Carton Label


    famo-20mg-ifc-100s


    NDC: 25000-087-82

    Famotidine Tablets USP 20 mg

    200's count Carton Label


    famo-20mg-ifc-200s


    NDC: 25000-087-82

    Famotidine Tablets USP 20 mg

    200's count Bottle Label


    famo-20mg-label-200s

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 10 MG 
    famotidine 10 mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeSQUARESize7mm
    FlavorImprint Code 86
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-086-363 in 1 CARTON03/10/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-086-031 in 1 CARTON03/10/2023
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-086-081 in 1 CARTON03/10/2023
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:25000-086-071 in 1 CARTON04/24/2024
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21754303/10/2023
    FAMOTIDINE 20 MG 
    famotidine 20 mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-087
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeSEMI-CIRCLE (D-shaped) Size9mm
    FlavorImprint Code 87
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-087-363 in 1 CARTON03/10/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-087-031 in 1 CARTON03/10/2023
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-087-081 in 1 CARTON03/10/2023
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:25000-087-051 in 1 CARTON04/24/2024
    450 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-087-821 in 1 CARTON02/15/2024
    5200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21754303/10/2023
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-086, 25000-087)