Bismuth Subsalicylate
FDA Label NDC 79481-0057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution, Inc. for the product Bismuth Subsalicylate (NDC 79481-0057). 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 drug facts, active ingredient (in each softgel) 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, warningsreye'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 stoo, ask a doctor before use if you have • fever • mucus in the stool, ask a doctor or pharmacist before use if you aretaking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel) 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
Warningsreye'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 Stoo
Ask A Doctor Before Use If You Have • Fever • Mucus In The Stool
Ask A Doctor Or Pharmacist Before Use If You Aretaking Any Drug For • Anticoagulation (Thinning The Blood) • Diabetes • Gout • Arthritis
When Using This Producta 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 Informationeach Softgel Contains:Salicylate 102 Mg • Very Low Sodium • Do Not Exceed 25°C
Inactive Ingredients Aerosil, Beeswax, D&C Red#33, Fd&C Yellow-6, Gelatin, Glycerin, Light Liquid Paraffin, Povidone, Purified Water, Sodium Carboxy Methyl Cellulose, Sorbitol Sorbitan Solution, Soya Lecithin, Titanium Dioxide
Questions Or Comments? 1-888-333-9792
Principle Display Panel
Carton.jpg (Carton)
* Please review the disclaimer below.
