STOMACH RELIEF, ULTRA STRENGTH- bismuth subsalicylate suspension

Stomach Relief, Ultra Strength by

Drug Labeling and Warnings

Stomach Relief, Ultra Strength by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg

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

DO NOT USE

Do not use if you have    ■ an ulcer
■ a bleeding problem       ■ black or bloody stool

ASK DOCTOR

Ask a doctor before use if you have
■ fever ■ mucus in stool

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

WHEN USING

When using this product a temporary, but harmless, darkening
of the stool and/or tongue may occur

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask health professional before use.

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

INGREDIENTS AND APPEARANCE

STOMACH RELIEF, ULTRA STRENGTH 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-558
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	1050 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-558-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	12/15/2020

Labeler - Marc Glassman, Inc. (094487477)