Label: CAREONE ACID RELIEF- famotidine tablet, film coated

  • NDC Code(s): 72476-299-71
  • Packager: Retail Business Services, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 7, 2022

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

View All Sections
  • Active ingredient (in each tablet)

    Famotidine 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.
    •
    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˚-25˚C (68˚-77˚F)
    •
    protect from moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose (monohydrate), magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, natural and artificial flavor, sucralose, titanium dioxide, triacetin

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    CAREone™

    Compare to the active ingredient in Maximum Strength Pepcid® AC

    MAXIMUM STRENGTH

    ACID RELIEF

    Famotidine Tablets, 20mg

    Acid Reducer

    Just one tablet prevents & relieves heartburn due to acid indigestion

    Releases a cooling sensation in mouth & throat

    Cool Mint Flavor

    Gluten Free

    Actual Size

    OUR PHARMACISTS RECOMMEND

    50 TABLETS

    acid relief image 1
    acid relief image 2
  • INGREDIENTS AND APPEARANCE
    CAREONE ACID RELIEF 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-299
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 32F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-299-711 in 1 CARTON06/03/2022
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735106/03/2022
    Labeler - Retail Business Services, LLC (967989935)
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!