791l-target-bismuth Subsalicylate 525 Mg / 30 Ml Oral Suspension

791l-target-bismuth Subsalicylate 525 Mg / 30 Ml Oral Suspension
SPL v2
SPL
SPL Set ID 28fba615-48ca-8d96-e063-6394a90a2797
Route
ORAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (525 mg)
Inactive Ingredients
Xanthan Gum D&c Red No. 22 Water D&c Red No. 28 Sucralose Glycerin Benzoic Acid

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

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 in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

Dosage and Administration

Directions

■ shake well before use

■ only use dose cup provided

■ adults and children 12 years and over:

- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea

- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

■ do not exceed 8 doses (240 mL) 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 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if

■ symptoms get worse or last more than 2 days

■ ringing in the ears or loss of hearing occurs

■ diarrhea lasts more than 2 days

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 the blood) ■ diabetes ■ gout ■ arthritis

Section 50569-3

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

Section 50570-1

Do not use if you have

■ an ulcer ■ a bleeding problem ■ bloody or black stool

Section 51727-6

Inactive ingredients benzoic acid, D&C red no. 22, D&C red no. 28, flavor, glycerin, purified water, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

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

Section 55105-1

Purpose

Upset stomach reliever and antidiarrheal

Section 55106-9

Active ingredient

(in each 30 mL dose)

Bismuth subsalicylate 525 mg

Section 60561-8

Other information

■ each 30 mL dose contains: salicylate 199 mg

■ keep tightly closed ■ protect from freezing

■ avoid excessive heat (over 104°F or 40°C)

Drug Facts

Drug Facts


Structured Label Content

Indications and Usage (34067-9)

Uses relieves

■ travelers’ diarrhea

■ diarrhea

■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

Dosage and Administration (34068-7)

Directions

■ shake well before use

■ only use dose cup provided

■ adults and children 12 years and over:

- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea

- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

■ do not exceed 8 doses (240 mL) 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 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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ symptoms get worse or last more than 2 days

■ ringing in the ears or loss of hearing occurs

■ diarrhea lasts more than 2 days

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 the blood) ■ diabetes ■ gout ■ arthritis

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if you have

■ an ulcer ■ a bleeding problem ■ bloody or black stool

Section 51727-6 (51727-6)

Inactive ingredients benzoic acid, D&C red no. 22, D&C red no. 28, flavor, glycerin, purified water, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Upset stomach reliever and antidiarrheal

Section 55106-9 (55106-9)

Active ingredient

(in each 30 mL dose)

Bismuth subsalicylate 525 mg

Section 60561-8 (60561-8)

Other information

■ each 30 mL dose contains: salicylate 199 mg

■ keep tightly closed ■ protect from freezing

■ avoid excessive heat (over 104°F or 40°C)

Drug Facts

Drug Facts


Advanced Ingredient Data


Raw Label Data

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