FDA Label for Stomach Relief, Ultra Strength

View Indications, Usage & Precautions

Stomach Relief, Ultra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Marc Glassman, Inc.. 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 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.

res


* Please review the disclaimer below.