Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 51013-321-54
  • Packager: PuraCap Pharmaceutical LLC
  • 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 November 28, 2017

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

View All Sections
  • Drug Facts

  • Active Ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    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

    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 days
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days
  • PREGNANCY OR BREAST FEEDING

    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.

  • 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 exceed 8 doses (16 tablets) 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 tablet contains: calcium 77 mg, salicylate 102 mg
    • store at 15°-30°C (59°-86°F)
    • protect from moisture
  • Inactive ingredients

    calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

  • Questions or comments

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Stomach Relief

    30 Tablets   15 Pouches (2 Tablets per Pouch)

    NDC: 51013-321-54

    CVSF34-00

    CVSB34-00

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-321
    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 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CHERRY (UNII: BUC5I9595W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPINK (light) Scoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code AP;045
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-321-5415 in 1 CARTON11/28/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33511/28/2017
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063MANUFACTURE(51013-321)
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!