Active Ingredient
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Topcare Stomach Relief Tablet
FDA Label NDC 76162-001
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 Topcare Stomach Relief (NDC 76162-001). 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 active ingredient, purpose, uses, reye’s syndrome, allergy alert, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal/Antacid
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 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.
Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- chew or dissolve in mouth
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed
Children under 12 years of age: ask a doctor
Other Information
- Phenylketonurics: contains phenylalanine 1.1mg per tablet
- Calcium content per tablet: 73mg
- save carton for full directions and warnings
- store at room temperature 15°– 30°C (59°– 86°F)
- do not use if cellophane unit is torn
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Package/Label Principal Display Panel
Stomach Relief (046 Stomach Relief 1)
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