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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 2, 2020

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

  • Drug Facts

    Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • PURPOSE

    Purpose

    Upset stomach reliever and anti-diarrheal

  • 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 at room temperature, in a dry place 
    • 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 Inc., the distributor of Pepto-Bismol®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2019 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-30287

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

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

    Stomach Relief

    DYE FREE

    Bismuth Subsalicylate 262mg

    Upset stomach reliever/Antidiarrheal

    Soothing relief for 5 symptoms:

    • Heartburn

    • Indigestion

    • Upset stomach

    • Nausea

    • Diarrhea

    Package Contains One Bottle

    40 Caplets

    5346-40GB-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 finalpart33507/06/2018
    Labeler - CVS Pharmacy, Inc. (062312574)