Revasol Peptic Relief

Revasol Peptic Relief
SPL v1
SPL
SPL Set ID 30dc3a0a-3496-4bdf-e063-6394a90a62fd
Route
ORAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (525 mg)
Inactive Ingredients
Anhydrous Citric Acid Salicylic Acid Xanthan Gum Methyl Salicylate Water Sodium Salicylate Sucralose Sodium Citrate Sorbic Acid D&c Red No. 22 D&c Red No. 28 Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

Description

Active ingredient (in each 30 mL dose) Purpose Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal


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:

• heartbun • indigestion • nausea • gas • belching • fullness

Dosage and Administration

Directions

• shake well before use • only with dosing cup provided

adults and children 12 years and over:

• 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for

diarrhea/traveler’s diarrhea

• 30 mL (1 dose) every 1/2 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 no more than 2 days

children under 12 years: ask a doctor

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Description

Active ingredient (in each 30 mL dose) Purpose Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal

Section 50565-1

Keep out of the 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 • 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

anhydrous citric acid, benzoic acid, D&C Red #22,

D&C Red #28, flavor, purified water, salicylic acid, sodium citrate, sodium

salicylate, sorbic acid, sucralose, xanthan gum.

Section 51945-4

Section 53413-1

Questions or comments 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9

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

Section 55105-1

Upset stomach reliever and antidiarrheal

Section 55106-9

Active ingredient (in each 30 mL dose) Purpose

Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal

Section 60561-8

Other information

each 30 mL dose contains: sodium 22 mg

• salicylate 249 mg • protect from freezing • avoid excessive heat (over 104°F

or 40°C)

TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken

or missing.


Structured Label Content

Indications and Usage (34067-9)

Uses

relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including:

• heartbun • indigestion • nausea • gas • belching • fullness

Dosage and Administration (34068-7)

Directions

• shake well before use • only with dosing cup provided

adults and children 12 years and over:

• 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for

diarrhea/traveler’s diarrhea

• 30 mL (1 dose) every 1/2 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 no 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 the 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 • 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

anhydrous citric acid, benzoic acid, D&C Red #22,

D&C Red #28, flavor, purified water, salicylic acid, sodium citrate, sodium

salicylate, sorbic acid, sucralose, xanthan gum.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Upset stomach reliever and antidiarrheal

Section 55106-9 (55106-9)

Active ingredient (in each 30 mL dose) Purpose

Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal

Section 60561-8 (60561-8)

Other information

each 30 mL dose contains: sodium 22 mg

• salicylate 249 mg • protect from freezing • avoid excessive heat (over 104°F

or 40°C)

TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken

or missing.


Advanced Ingredient Data


Raw Label Data

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