Label: BISMUTH SUBSALICYLATE tablet, film coated

  • NDC Code(s): 69842-346-12, 69842-346-28
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Drug Facts

    Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • PURPOSE

    Purpose

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves:

    ■ travelers’ diarrhea

    ■ diarrhea

    ■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

  • 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

    • an ulcer
    • a bleeding problem
    • bloody or black stool

    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 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 a doctor if 

    • symptoms get worse or last more than 2 dyas.
    • 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

    • swallow caplets with water, do not chew
    • adults and children 12 years and over: 2 caplets (1 dose) every 1/2 to 4 cpalets (2 doses) every hour as needed for diarrhea
    • 2 cpaltes (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (16 caplets) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other Information

    • each caplet contains: salicylate 102 mg
    • store in a dry place at 15º - 30º C (59º - 86º F)
    • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

  • INACTIVE INGREDIENT

    croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    RETAIN CARTON FOR FULL LABELING INFORMATION

    *This product is not manufactured or distributed by Procter & Gamble Company, the owner of registered trademark Pepto-Bismol®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2024 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-30287

    Product of Mexico. Manufactured and packaged in U.S.A. using domestic and improted ingredients.

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Pepto-Bismol® Caplets*

    Stomach Relief

    Bismuth Subsalicylate 262mg

    Upset stomach reliever/Antidiarrheal

    Relievesr 5 symptoms:

    • Heartburn

    • Indigestion

    • Upset stomach

    • Nausea

    • Diarrhea

    40 Caplets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 
    bismuth subsalicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIACETIN (UNII: XHX3C3X673)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-346-281 in 1 CARTON07/06/2018
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-346-121 in 1 CARTON07/06/2018
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00107/06/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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