Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Stomach Relief Tablet
FDA Label NDC 37835-207
17 label sections · Submitted to the FDA by Bi-mart · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Stomach Relief (NDC 37835-207). 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 (in each tablet), purpose, uses, reye’s syndrome:, allergy alert:, do not use ifyou 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
Purpose
Antidiarrheal/Upset stomach reliever
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 or 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 Ifyou 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
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
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- 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 no more than 2 days
- Children under 12 years:ask a doctor
Other Information
- each tablet contains:calcium 73 mg, salicylate 102 mg
- phenylketonurics:contains phenylalanine 1.1 mg per tablet
- do not use if seal around tablet is broken or damaged
- store at 15° to 30°C (59° to 86°F)
- protect from moisture
- avoid excessive heat (above 104°F or 40°C)
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Questions?
call toll-free 1-844-912-4012
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