Stomach Relief, Ultra Strength

Stomach Relief, Ultra Strength
SPL v3
SPL
SPL Set ID 8e47d007-237c-45c7-88c5-83953a06e4bd
Route
ORAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1050 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Water Saccharin Sodium Salicylic Acid Sodium Salicylate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-15

Description

Drug Facts


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach

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

indigestion ■ nausea ■ gas ■ belching

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product a temporary, but harmless, darkening

of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are

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

■ diabetes ■ gout ■ arthritis

Section 50569-3

Ask a doctor before use if you have

■ fever ■ mucus in stool

Section 50570-1

Do not use if you have    ■ an ulcer

■ a bleeding problem       ■ black or bloody stool

Section 51727-6

Inactive ingredients benzoic acid, D&C red #22, D&C red #28,

flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham gum

Section 53414-9

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

Section 55105-1

Purposes

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

                                                                and antidiarrheal

Section 55106-9

Active ingredient

(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 1050 mg

Section 60561-8

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

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


Structured Label Content

Indications and Usage (34067-9)

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach

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

indigestion ■ nausea ■ gas ■ belching

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening

of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

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

■ diabetes ■ gout ■ arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ fever ■ mucus in stool

Section 50570-1 (50570-1)

Do not use if you have    ■ an ulcer

■ a bleeding problem       ■ black or bloody stool

Section 51727-6 (51727-6)

Inactive ingredients benzoic acid, D&C red #22, D&C red #28,

flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham gum

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

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

                                                                and antidiarrheal

Section 55106-9 (55106-9)

Active ingredient

(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 1050 mg

Section 60561-8 (60561-8)

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

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


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