Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Winco Foods Stomach Relief Tablet, Chewable
FDA Label NDC 67091-364
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods Llc for the product Winco Foods Stomach Relief (NDC 67091-364). 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, 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
Upset stomach reliever and antidiarrheal
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 over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea▪ 2 tablets (1 dose) every ½ 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: ask a doctor▪ drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Other Information
▪ each tablet 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 printed inner wrap is broken or missing.
Inactive Ingredients
D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.
Questions?
Call 800-824-1706 Monday – Friday 9am – 4pm MST
Principal Display
Winco® FOODS
NDC# 67091-364-30
Compare to the active ingredient in PEPTO-BISMOL® Chewable Tablets
Stomach Relief
BISMUTH SUBSALICYLATE/
UPSET STOMACH RELIEVER & ANTI-DIARRHEAL
Soothing Relief for: Upset stomach, Indigestion, Nausea, Heartburn, Diarrhea
The Supermarket Low Price Leader®
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Comments & Question?
800-824-1706 www.wincofoods.com
30 Chewable Tablets
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
*This product is not manufactured or distributed by PROCTER & GAMBLE INC., distributor of PEPTO-BISMOL® Chewable Tablets
If any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
Winco Foods Stomach Relief 30 Chewable Tablets (172gnp)
* Please review the disclaimer below.
