Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled

  • NDC Code(s): 68210-4170-1
  • Packager: Spirit Pharmaceuticals 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 December 1, 2022

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

  • Drug Facts

  • Active Ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • 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 if you are

    you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis

  • When using this product

    • symptoms get worse or last more than 2 days • 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 right away. (1-800-222-1222)

  • Directions

    • swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) 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 softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

  • Inactive ingredients

    Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Pouch

    Stomach Relief

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4170
    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
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    SILICON (UNII: Z4152N8IUI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 262
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4170-110 in 1 POUCH; Type 0: Not a Combination Product11/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33511/22/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)