Other
Drug Facts
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
Stomach Relief Suspension
FDA Label NDC 57243-557
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Consumer Value Products, Inc. for the product Stomach Relief (NDC 57243-557). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg
Otc - Purpose
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Indications & Usage
Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset
stomach due to overindulgence of food and drink including:
■ heart burn ■ indigestion ■ nausea ■ gas ■ belching
Warnings
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.
Otc - Do Not Use
Do not use if you have ■ an ulcer ■ a bleeding problem
■ black or bloody stool
Otc - Ask Doctor
Ask a doctor before use if you have
■ fever ■ mucus in stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the
blood) ■ diabetes ■ gout ■ arthritis
Otc - When Using
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
Otc - Stop Use
Slop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose
(30 mL or 2 TBSP) every 1/2 to 1 hour as
needed
■ do not exceed 8 doses (240 mL or 16 TBSP)
in 24 hours
■ use until diarrhea stops but not more than 2
days
■ children under 12 years: ask a doctor
■ drink plenty of clear fluids to help prevent
dehydration caused by diarrhea
Other Safety Information
Other information ■ each 30 mL dose
contains: sodium 13 mg, salicylate 256 mg
■ protect from freezing
■ avoid excessive heat (over 104°F or 40°C)
■ Low sodium
Inactive Ingredient
Inactive ingredients benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Otc - Questions
Questions? 1-877-798-5944
Principal Display Panel
CVP®
HEALTH
*COMPARE TO
PEPTO-BISMOL®
ACTIVE INGREDIENT
Stomach
Relief
PROTECTIVE COATING ACTION
Bismuth Subsalicylate
SOOTHING RELIEF FOR:
UPSET STOMACH
HEARTBURN
INDIGESTON
NAUSEA
COMMON DIARRHEA
8 FL OZ (237 mL)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™.
DISTRIBUTED BY Made in USA
CONSUMER VALUE PRODUCTS, INC. LR-102 REV01
P.O. BOX 6115 TEMPLE, TX 76502
CVPproducts.com
7 61706 16202 6 PEEL
HERE
Stomach Relief by Consumer Value Products, Inc.
res
* Please review the disclaimer below.
