FDA.reportPublic FDA data

Revasol Tussin DM Cough Suppressant Expectorant

Manufacturer
Rnv LLC
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:46:56

Label at a glance#

ProductRevasol Tussin DM Cough Suppressant Expectorant
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg
Guaifenesin 100 mg

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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

AgeDose
adults and children 12 years of age and over10 mL every 4 hours
children 6 to under 12 years of age5 mL every 4 hours
children under 6 years of agedo 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 SECTION

Inactive ingredients citric acid, flavors, glycerin, menthol, propylene glycol,
sodium benzoate, sucralose, water.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL REVASOL DM 316LABEL REVASOL DM 316

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-316-16Revasol Tussin DM Cough Suppressant Expectorant474 mL in 1 BOTTLELIQUID4741

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84379-31684379-316-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SODIUM BENZOATEOJ245FE5EUIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
ndc (package): 84379-316-16
ndc (product): 84379-316
ndc11 (package): 84379031616
spl id: 4b7fd320-2f3a-fa1a-e063-6294a90ada9e
spl set id: 4b7fd320-2f39-fa1a-e063-6294a90ada9e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.