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 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

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 yearsof 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: 305-821-4002
Monday - Friday (9 AM - 5 PM EST)

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

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

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)