Active Ingredient(S)
Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)
Stomach Relief Tablet
FDA Label NDC 83324-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Stomach Relief (NDC 83324-130). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal/Antacid
Use(S)
- 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
- an ulcer
- a bleeding problem
- bloody or black stool
Ask A Doctor Before Use If
- 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
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
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
If Pregnant Or Breastfeeding,
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
Adults and children 12 years and over:
- 2 tablets (1 dose) every 1/2; hour or 4 tablets (2 doses) every
hour as needed for diarrhea - 2 tablets (1 dose) every 1/2; hour as needed for overindulgence (upset
stomach, heartburn, indigestion, nausea) - do not exceed 8 doses (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
Other Information
Phenylketonurics: contains phenylalanine 1.1mg per tablet
Calcium content per tablet: 73mg
- 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
Principal Display Panel
Stomach Relief
* Please review the disclaimer below.
