Otc - Active Ingredient
Active ingredient (in each 5 mL)
Purpose
Diphenhydramine HCl 12.5mg..........................................................Antihistamine
Revasol Childrens Allergy Liquid
FDA Label NDC 84379-286
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 Childrens Allergy (NDC 84379-286). 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
Purpose
Antihistamine
Indications & Usage
Uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Warnings
Warnings
Otc - Do Not Use
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even on one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
• a breathing problem such as chronic bronchitis • glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
• marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children
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 (1-800-222-1222).
Dosage & Administration
Directions
• find the right dose on chart below
• mL=mililiter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| Age | Dose |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Safety Information
Other information
•
each 5 mL contains: sodium 4 mg
• store between 15-30°C (59-86°F).
•
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium
citrate, sorbitol solution, sucralose.
Otc - Questions
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
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