Otc - Active Ingredient
Active ingredient (in each 30 mL dose cup) Purpose
Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid
Revasol Sleep Aid Liquid
FDA Label NDC 84379-284
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 Sleep Aid (NDC 84379-284). 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 - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Nightime sleep-aid
Indications & Usage
Uses
• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Otc - Ask Doctor
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or
tranquilizers
Otc - When Using
When using this product
• avoid alcoholic beverages
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuosly for more than 2
weeks. Insomnia may be a symptom of serious underlying medical ilness.
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 (1-800-222-1222).
Dosage & Administration
Directions
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided
| Age | Dose |
| adults and children
12 years and over | 30 mL at bedtime if needed
or as directed by a doctor |
| children under 12 years | do not use |
Other Safety Information
Other information
•
each 30 mL dose cup 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, FD&C Blue #1, FD&C Red #40,
flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate,
sodium citrate, sorbitol, sucralose.
Otc - Questions
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
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