Otc - Active Ingredient
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Revasol Tussin Dm Cough Suppressant Expectorant Liquid
FDA Label NDC 84379-316
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 Dm Cough Suppressant Expectorant (NDC 84379-316). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cough Suppressant
Expectorant
Indications & Usage
Uses • temporarily relieves cough as may occur with the common cold • helps
loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
passageways of bothersome mucus.
Warnings
Warnings
Do not use • if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or
Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have • a cough that is accompanied by excessive
phlegm (mucus) • a persistent or chronic cough such as occurs with smoking,
asthma, chronic bronchitis, or emphysema
Otc - Stop Use
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
• do not exceed more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL=mililiter • TSP=teaspoonful
| Age | Dose |
| adults and children 12 years of age and over | 10 mL every 4 hours |
| children 6 to under 12 years of age | 5 mL every 4 hours |
| children under 6 years of age | do not use |
Other Safety Information
Other Information
• Store at room temperature 15-30°C (59-86°F). Do not refrigerate.
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.
Inactive Ingredient
Inactive ingredients citric acid, flavors, glycerin, menthol, propylene glycol,
sodium benzoate, sucralose, water.
Otc - Questions
Questions or comments? 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
Other
Made in USA
Distributed by:
RNV LLC
14501 NW 60 Ave,
Miami Lakes, FL 33014
* Please review the disclaimer below.
