STOMACH RELIEF, ULTRA STRENGTH- bismuth subsalicylate suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Marc Glassman, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Bismuth subsalicylate ....................... Upset stomach reliever                                                                 and antidiarrheal Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching Do not use if you have    ■ an ulcer ■ a bleeding problem       ■ black or bloody stool 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
Authorization status:
OTC monograph final
Authorization number:
68998-558-28

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STOMACH RELIEF, ULTRA STRENGTH- bismuth subsalicylate suspension

Marc Glassman, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Stomach Relief, Ultra Strength

Drug Facts

Active ingredient

(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 1050 mg

Purposes

Bismuth subsalicylate ....................... Upset stomach reliever

and antidiarrheal

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach

due to overindulgence of food and drink including: ■ heart burn ■

indigestion ■ nausea ■ gas ■ belching

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 if you have ■ an ulcer

■ a bleeding problem ■ black or bloody stool

Ask a doctor before use if you have

■ fever ■ mucus in stool

Ask a doctor or pharmacist before use if you are

taking any drug for ■ anticoagulation (thinning of the blood)

■ diabetes ■ gout ■ arthritis

When using this product a temporary, but harmless, darkening

of the stool and/or tongue may occur

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

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

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

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 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 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-Bismol

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 Bismol

Distributed by: LR-144

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

Lot.

Exp.

TM

TM

STOMACH RELIEF, ULTRA STRENGTH

bismuth subsalicylate suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 9 9 8 -558

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID -

UNII:O414PZ4LPZ)

BISMUTH

SUBSALICYLATE

10 50 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

D&C RED NO . 2 2 (UNII: 16 78 RKX8 RT)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SALICYLIC ACID (UNII: O414PZ4LPZ)

SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP)

XANTHAN GUM (UNII: TTV12P4NEE)

Marc Glassman, Inc.

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 9 9 8 -558 -28

354 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/15/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt335

12/15/20 20

Labeler -

Marc Glassman, Inc. (094487477)

Revised: 12/2020

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