Active Ingredient (In Each 15 Ml)
Bismuth subsalicylate 525 mg
Stomach Relief Liquid
FDA Label NDC 55910-837
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. (dollar General & Rexall) for the product Stomach Relief (NDC 55910-837). 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 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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/Antidiarrheal
Uses
relieves
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- fullness
- belching
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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 Childen.
In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
Directions
- do not take more than 8 doses (120 mL) 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
- mL = milliliter
- shake well before using
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over:
- 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
- 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- children under 12 years of age: ask a doctor
Other Information
- each 15 mL contains: sodium 5 mg
- each 15 mL contains: salicylate 206 mg
- low sodium
- keep tightly closed
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients
benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
Questions Or Comments?
Call toll free 1-888-309-9030
Principal Display Panel
ULTRA
Stomach Relief
Bismuth Subsalicylate 525 mg per 15 mL
Upset stomach reliever / antidiarrheal
Soothing relief for
- Indigestion
- Upset stomach
- Diarrhea
- Heartburn
- Nausea
2x Strength Per Ounce†
Alcohol free • Sugar free
FL OZ (mL)
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072 USA
Package Label
DollarGeneral Peptic Relief Ultra Relief
* Please review the disclaimer below.
