Label: BISMUTH SUBSALICYLATE capsule, gelatin coated

  • NDC Code(s): 68210-5018-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient ( in each softgel)                        Purpose

    Bismuth subsalicylate 262 mg ................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 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.

  • Directions

    •  swallow with water, do not chew
    •  adults and children 12 years and over:
    •  2 softgels every ½ hour or 4 softgels every hour as needed for
      diarrhea
    •  2 softgels every ½ hour to 1 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 102 mg
    • very low sodium
    •  do not exceed 25°C
  • Inactive ingredients

    beeswax, collidal silicon dioxide, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, povidone, purified water, soya lecithin, sodium carboxymethyl cellulose, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Stomach relief

    Bismuth Subsalicylate 262 mg
    Upset Stomach Reliever/Antidiarrheal

    Soothing relief for 5 symptoms:
    • Heartburn • Indigestion • Upset stomach
    • Nausea • Diarrhea

    12 Softgels

    Stomach Relief

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 
    bismuth subsalicylate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-5018
    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
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Oblong shaped) Size21mm
    FlavorImprint Code 262
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-5018-11 in 1 CARTON07/19/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00807/19/2023
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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!