Topcare Stomach Relief Original Strength

Topcare Stomach Relief Original Strength is an FDA-registered drug product whose active ingredient is BISMUTH SUBSALICYLATE. It is labelled by TopCo Associates, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 76162-001, application M008, label effective 20181214. It is one of 62 FDA drug label records sharing the active ingredient BISMUTH SUBSALICYLATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BISMUTH SUBSALICYLATE are most often described in connection with: relieves travelers, diarrhea diarrhea, upset stomach, due overindulgence, drink including, heartburn indigestion, nausea gas, belching fullness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness

Directions chew or dissolve in mouth Adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed do not exceed 16 tablets in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

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 of the blood) diabetes gout arthritis 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 When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur If pregnant or breast-feeding ask a health professional before use.

FDA lists 62 drug label records with BISMUTH SUBSALICYLATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Topcare Stomach Relief Original Strength used for?
Uses relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness

Who makes Topcare Stomach Relief Original Strength?
TopCo Associates, LLC is the labeler of record for Topcare Stomach Relief Original Strength. 62 FDA label records share the active ingredient BISMUTH SUBSALICYLATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Topcare Stomach Relief Original Strength come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Topcare Stomach Relief Original Strength prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BISMUTH SUBSALICYLATE?
Yes. 62 FDA drug label records list BISMUTH SUBSALICYLATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Topcare Stomach Relief Original Strength been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.