Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Stomach Relief Tablet, Chewable
FDA Label NDC 55301-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Your Military Exchange for the product Stomach Relief (NDC 55301-124). 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 chewable tablet), purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking any drug for, 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
Anti-diarrheal/ upset stomach reliever
Uses
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 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
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
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222
Directions
▪ chew completely or dissolve tablets in mouth. Do not swallow tablets whole.▪ adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed▪ do not exceed 8 doses (16 caplets) in 24 hours▪ use until diarrhea stops but not more than 2 days▪ children under 12 years: ask a doctor▪ drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Other Information
▪ each caplet contains: salicylate 102 mg▪ store at room temperature.▪ avoid excessive heat▪ keep this carton for future reference on full labeling
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.
Inactive Ingredients
D&C Red No. 27, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.
Questions?
1-866-467-2748
Principal Display
exchange select™
BDC# 55301-124-30
Compare To the active ingredient Pepto-Bismol®*
Stomach relief
Bismuth Subsalicylate 262 mg
Upset Stomach reliever antidiarrheal.
5 symptom digestive relief
- Heartburn
- Indigestion
- Nausea
- Upset stomach
- Diarrhea
Original Flavor
30 CHEWABLE TABLETS
QUALITY VALUE
“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
By: Raritan Pharmaceuticals Inc.
8 Joanna Court, East
Brunswick, NJ 08816
*This product is not manufactured or distributed by The Procter & Gamble Inc., owner of the registered trademark Pepto-Bismol®.
Original Flv Bismuth Subsalicylate 30 Chewable Tablets (172gnp)
* Please review the disclaimer below.
