REVASOL TUSSIN- guaifenesin liquid

Revasol Tussin by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Guafenesin 200 mg

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

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
• 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.

QUESTIONS

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

OTHER SAFETY INFORMATION

Other Information:

• store at room temperature 15-30°C (59-86ºF). Do not refrigerate

TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

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 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-313
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-313-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2024
2	NDC: 84379-313-16	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	08/19/2024

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-313)