Other
Drug Facts
Stomach Relief, Ultra Strength Suspension
FDA Label NDC 68998-558
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Stomach Relief, Ultra Strength (NDC 68998-558). 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 1050 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.
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
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 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 hour as needed
■ do not exceed 4 doses (120 mL or 8 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 cup contains: sodium 13 mg, salicylate 455 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
Marc's Product Label
NDC 68998-558-28 * Compare to the active
ingredients in Pepto-BismolTM
Maximum Strength
Marc's
ULTRA STRENGTH
Stomach Relief
Antidiarrheal / Upset Stomach Reliever
Bismuth subsalicylate
5 Symptoms Relief of
• Nausea • Upset Stomach•
• Heartburn • Diarrhea
• Indigestion
12 FL OZ (354 mL)
TAMPER EVIDENT: Do not use if imprinted shrinkband is
missing or broken
*Thls product is not manufactured or dlstnbuted by Procter & Gamble, Inc"
distributor of Pepto BismolTM
Distributed by: LR-144
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130
Lot.
Exp.
558-28 (558 28)
res
* Please review the disclaimer below.
