Label: TOPCARE ACID REDUCER- famotidine tablet, film coated

  • NDC Code(s): 36800-141-65, 36800-141-72, 36800-141-75
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 21, 2022

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

View All Sections
  • Active ingredient (in each tablet)

    Famotidine 10 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.
    •
    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
    •
    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
  • Inactive ingredients

    carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health

    COMPARE TO PEPCID® AC ACTIVE INGREDIENT

    ORIGINAL STRENGTH

    Acid Reducer

    FAMOTIDINE TABLETS, 10 mg

    ACID REDUCER

    Just One Tablet

    Prevents & Relieves Heartburn Due to Acid Indigestion

    30 TABLETS

    actual size

    acid reducer image
  • INGREDIENTS AND APPEARANCE
    TOPCARE ACID REDUCER 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-141
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-141-721 in 1 CARTON09/11/2009
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:36800-141-6530 in 1 CARTON10/13/2009
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:36800-141-751 in 1 CARTON03/22/2021
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07540009/11/2009
    Labeler - Topco Associates LLC (006935977)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!