Active Ingredient (In Each 30 Ml Dose)
Bismuth subsalicylate 525 mg
Stomach Relief Liquid
FDA Label NDC 72476-736
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Care One (retail Business Services, Llc.) for the product Stomach Relief (NDC 72476-736). 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 30 ml dose), 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 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
- 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 Poison Control Center (1-800-222-1222) right away
Directions
- 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
- 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) 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
- each 30 mL contains: sodium11 mg
- each 30 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 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Pepto-Bismol®*
REGULAR STRENGTH
STOMACH RELIEF
Bismuth Subsalicylate 525 mg /
Upset Stomach Reliever / Antidiarrheal
Cherry Flavor
RELIEVES:
NAUSEA, HEARTBURN, INDIGESTION, UPSET STOMACH, DIARRHEA
Alcohol free
Sugar free
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company, Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: FOODHOLD U.S.A., LLC LANDOVER, MD 20785
Package Label
CARE ONE Regular Strength Stomach Relief
* Please review the disclaimer below.
