REVASOL TUSSIN DM COUGH SUPPRESSANT EXPECTORANT- dextromethorphan hbr, guaifenesin liquid

Revasol Tussin DM Cough Suppressant Expectorant by

Drug Labeling and Warnings

Revasol Tussin DM Cough Suppressant Expectorant by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan HBr 10 mg
Guaifenesin 100 mg

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.

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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

QUESTIONS

Questions or comments? 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

SPL UNCLASSIFIED SECTION

Made in USA

Distributed by:
RNV LLC
14501 NW 60 Ave,
Miami Lakes, FL 33014

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL TUSSIN DM COUGH SUPPRESSANT EXPECTORANT 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-316
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-316-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/01/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-316)