FDA Label for Stomach Relief Regular Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 30 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDEN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Stomach Relief Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Care One (retail Business Services, Llc.). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 30 Ml)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/Antidiarrheal
Uses
relieves
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- gas
- indigestion
- nausea
- 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 right away. (1-800-222-1222)
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 to 1 hour as needed
- 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: sodium 10 mg
- each 30 mL contains: salicylate 248 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, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose
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
1-877-846-9949
Package Label
CARE ONE Regular Strength Stomach Relief
* Please review the disclaimer below.