Bismuth Subsalicylate
FDA Label NDC 36800-710

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Bismuth Subsalicylate (NDC 36800-710). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, reye's syndrome:, allergy alert: contains salicylate. do not take if you are, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

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

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 102.33 mg
  • very low sodium
  •  do not exceed 25°C

Inactive Ingredients

aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Questions Or Comments?

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Stomach Relief

BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal

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

24 SOFTGELS

* Please review the disclaimer below.