Otc - Active Ingredient
Active ingredient (in each 30 mL dose) Purpose
Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal
Revasol Peptic Relief Liquid
FDA Label NDC 84379-283
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rnv Llc for the product Revasol Peptic Relief (NDC 84379-283). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Upset stomach reliever and antidiarrheal
Indications & Usage
Uses
relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including:
• heartbun • indigestion • nausea • gas • belching • fullness
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
Otc - Do Not Use
Do not use if you have • an ulcer • a bleeding problem • bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have • fever • mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
• anticoagulation (thinning the blood) • diabetes • gout • arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool
and/or tongue may occur
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the 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 • 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
Other Safety Information
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.
Inactive Ingredient
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.
Otc - Questions
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
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