Label: FAMOTIDINE 20 MG tablet, coated

  • NDC Code(s): 25000-124-68, 25000-124-84, 25000-124-94
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 6, 2025

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

  • ACTIVE INGREDIENT(S)

    Active ingredient (in each tablet)
    Famotidine USP 20 mg

  • PURPOSE

    Purpose 
    Acid reducer

  • USE(S)

    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

    Warnings

    Allergy alert:
    Do not use if you are allergic to famotidine or other acid reducers

  • DO NOT USE

    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

    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

    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 DOCTOR IF

    Stop use and ask a doctor if
    •your heartburn continues or worsens
    •you need to take this product for more than 14 days

  • PREGNANCY/BREASTFEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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

    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

    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
    •Meets USP dissolution test 2

  • INACTIVE INGREDIENTS

    Inactive ingredients carnauba wax, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium saccharin, talc, titanium dioxide

  • QUESTIONS OR COMMENTS

    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


    NDC: 25000-124-94
    Famotidine Tablets USP 20 mg- Cool mint flavor
    25's (5 x 5's blister) count Carton Label

    famotidine-20mg-5x5s-cool-mint-blister-ifc


    NDC: 25000-124-84
    Famotidine Tablets USP 20 mg- Cool mint flavor
    25's count Bottle Label

     

    famotidine-20mg-25s-cool-mint-label

    NDC: 25000-124-84
    Famotidine Tablets USP 20 mg- Cool mint flavor
    25's count Carton Label

    famotidine-20mg-25s-cool-mint-ifc




    NDC: 25000-124-68
    Famotidine Tablets USP 20 mg- Cool mint flavor
    300's count Bottle Label

    famotidine-20mg-300s-cool-mint-label



  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 20 MG 
    famotidine 20 mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorMINTImprint Code 124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-124-945 in 1 CARTON05/23/2025
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-124-841 in 1 CARTON05/23/2025
    225 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-124-68300 in 1 BOTTLE; Type 0: Not a Combination Product05/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21754305/23/2025
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-124)