Label: CAREONE STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 72476-173-72
  • Packager: Retail Business Services, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2024

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  • ACTIVE INGREDIENT(S)

    Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

  • PURPOSE

    Upset stomach reliever and anti-diarrheal

  • USE(S)

    relieves: 

    • diarrhea 
    • heartburn 
    • indigestion 
    • nausea
    • upset stomach associated with these symptoms 
  • WARNINGS

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    ____________________________________________________________________________________________________________

    Allergy alert: Contains salicylate. Do not take if you are 

    • allergic to salicylates (including aspirin)
    • taking other salicylate products
  • DO NOT USE IF YOU HAVE

    • bloody or black stool
    • an ulcer
    • a bleeding problem
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • fever
    • mucus in the stool
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    taking any drug for 

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis

  • WHEN USING THIS PRODUCT

    a temporary, but harmless darkening of the stool and/or tongue may occur.

  • STOP USE AND ASK DOCTOR IF

    • symptoms get worse 
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 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 immediately.


  • DIRECTIONS

    • chew or dissolve in mouth 
    • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed 
    • do not take more than 8 doses (16 tablets) in 24 hours
    • children under 12 years: ask a doctor 
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea 
  • OTHER INFORMATION

    • each tablet contains:
    • sodium less than 1 mg 
    • salicylate 102 mg
    • very low sodium 
    • avoid excessive heat (over 104oF or 40oC).
    • TAMPER EVIDENT: Do not use if individual compartments are torn or open.
  • INACTIVE INGRADIENTS

    calcium carbonate, D&C red 27 aluminum lake, flavor, Magnesium stearate, mannitol, pregelatinized  starch, saccharin sodium.

  • PRINCIPAL DISPLAY PANEL

    C 72476-173-72

    CAREoneTM

    Compare to active ingredient of Pepto-Bismol® Chewable Tablets*

    Stomach Relief Tablets

    Bismuth Subsalicylate 262 mg

    Upset Stomach/Antidiarrheal

    EASY TO CHEW

    FOR RELIEF OF:

    • UPSET STOMACH 
    • INDIGESTION 
    • HEARTBURN
    • NAUSEA
    • DIARRHEA

    Actual Size

    30 Chewable Tablets

    careone-122.jpg

    careone-122.jpg

  • INGREDIENTS AND APPEARANCE
    CAREONE STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorMINTImprint Code G122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-173-726 in 1 BOX11/26/2024
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00811/26/2024
    Labeler - Retail Business Services, LLC. (967989935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(72476-173)
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