Label: MAXIMUM STRENGTH ACID REDUCER- famotidine tablet

  • NDC Code(s): 11673-697-01, 11673-697-05, 11673-697-20, 11673-697-52
  • Packager: TARGET CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 13, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Famotidine USP 20 mg

  • PURPOSE

    Purpose

    Acid reducer

  • INDICATIONS & USAGE

    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

    • 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.

  • DOSAGE & ADMINISTRATION

    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 minutesbefore 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

  • STORAGE AND HANDLING

    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 INGREDIENT

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

  • QUESTIONS

    Questions or comments? Call 1-800-910-6874

  • SPL UNCLASSIFIED SECTION

    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

  • PRINCIPAL DISPLAY PANEL

    famotidine-20mg-200s-labelfamotidine-20mg-200s-ifcfamotidine-20mg-100s-ifcfamotidine-20mg-50s-labelfamotidine-20mg-50s-ifcfamotidine-20mg-25ct-ifc

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ACID REDUCER 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-697
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeSEMI-CIRCLE (D-shaped) Size9mm
    FlavorImprint Code 87
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-697-525 in 1 CARTON05/15/2024
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11673-697-051 in 1 CARTON05/15/2024
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11673-697-012 in 1 CARTON05/15/2024
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11673-697-201 in 1 CARTON05/15/2024
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21754305/15/2024
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(11673-697)
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