FDA Label for Stomach Relief Regular Strength
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTHER SAFETY INFORMATION
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Stomach Relief Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg
Otc - Purpose
Purposes
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
recovenng 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.
Other Safety Information
Allergy alert:Contains salicylate. Do not take if you are
• allergic to salicylates (including aspirin)
• taking other salicylate products
Other information • each 30 mL dose
contains: sodium 13 mg, salicylate 256 mg
• protect from freezing
• avoid excessive heat (over 104ο F or 40ο C)
• Low sodium
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
Stop 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 a 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 belore 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
Inactive Ingredient
Inactive ingredients benzoic acid, D&C red
#22, D&C red # 28, flavor, purified water, saccharin
sodium, salicylic acid, sodium salicylate, xanthan gum
Otc - Questions
Ouestions? 1-877-798-5944.
Principal Display Panel
Premier
Value®
COMPARE TO THE ACTIVE
INGREDIENTS IN
PEPTO BISMOLTM*
STOMACH
RELIEF
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
Regular Strength
5 Symptom Relief of:
• Nausea • Heartburn
• Indigestion • Upset stomach
• Diarrhea
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distnbuted by Procter & Gamble,
Inc., the distributor of Pepto-BismolTM.
Distributed By: Made in USA
Pharmacy Value Alliance, LLC LR-121
407 East Lancaster Avenue,
Wayne, PA 19087
8 40986 03581 4
→DRUG fACTS CONTINUED ON BACK →
8 fl oz pkg.
12 fl oz pkg.
res
* Please review the disclaimer below.