Otc - Active Ingredient
Guafenesin 200 mg
Revasol Tussin Liquid
FDA Label NDC 84379-313
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 Tussin (NDC 84379-313). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant
Indications & Usage
Uses
helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of bothersome mucus.
Warnings
Warning
Ask a doctor before use if you have • a persistent or chronic
cough such as occurs wiht smoking, asthma, chronic bronchitis, or
emphysema or where cough is accompanied by excessive phlegm
(mucus)
Stop use and ask a doctor if • cough persists for more than 1
week, tends to recur, or is accompanied by a fever, rash, or
persistent headache. A persistent cough may be a sign of a serious
condition.
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 accidental overdose,
get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Directions:
do not exceed more than 6 doses in any 24-hour period
shake well before use
measure only with dosing cup provided
keep dosing cup with product
mL=mililiter TSP=teaspoonful
this adult product is not intended for use in children
| Age | Dose |
| adults and children 12 years of age and over | 10 mL (2 teaspoonful) every 4 hours |
| children under 12 years of age | do not use |
Inactive Ingredient
Inactive ingredients citric acid, FD&C #40, flavors, glycerin,
menthol, propylene glycol, sodium benzoate, sucralose, water.
Otc - Questions
Questions or comments: 305-821-4002
Monday - Friday (9 AM - 5 PM EST)
Package Label.Principal Display Panel
Revasol (Revasol)
* Please review the disclaimer below.
