Revasol Tussin Cherry Flavor Ndc 84379-313-04, 84379-313-16

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Water Anhydrous Citric Acid Propylene Glycol Menthol Glycerin Sodium Benzoate Fd&c Red No. 40 Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-19

Medication Information

Warnings and Precautions

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)

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial

secretions to rid the bronchial passageways of bothersome mucus.

Dosage and 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

Description

Guafenesin 200 mg

Section 42229-5

Made in USA

Distributed by:

RNV LLC

14501 NW 60 Ave,

Miami Lakes, FL 33014

Section 50565-1

Keep out of the reach of children. In case of accidental overdose,

get medical help or contact a Poison Control Center right away.

Section 50566-9

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.

Section 51727-6

Inactive ingredients citric acid, FD&C #40, flavors, glycerin,

menthol, propylene glycol, sodium benzoate, sucralose, water.

Section 51945-4

Section 53413-1

Questions or comments? 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9

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

use.

Section 55105-1

Expectorant

Section 55106-9

Guafenesin 200 mg

Section 60561-8

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.

Structured Label Content

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial

secretions to rid the bronchial passageways of bothersome mucus.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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)

Section 42229-5 (42229-5)

Made in USA

Distributed by:

RNV LLC

14501 NW 60 Ave,

Miami Lakes, FL 33014

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of accidental overdose,

get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.

Section 51727-6 (51727-6)

Inactive ingredients citric acid, FD&C #40, flavors, glycerin,

menthol, propylene glycol, sodium benzoate, sucralose, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9 (53414-9)

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

use.

Section 55105-1 (55105-1)

Expectorant

Section 55106-9 (55106-9)

Guafenesin 200 mg

Section 60561-8 (60561-8)

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.", "34068-7": "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", "34071-1": "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)", "42229-5": "Made in USA Distributed by: RNV LLC 14501 NW 60 Ave, Miami Lakes, FL 33014", "50565-1": "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "51727-6": "Inactive ingredients citric acid, FD&C #40, flavors, glycerin, menthol, propylene glycol, sodium benzoate, sucralose, water.", "53413-1": "Questions or comments? 1-888-446-4753 Monday - Friday (9 AM - 5 PM EST)", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Expectorant", "55106-9": "Guafenesin 200 mg", "60561-8": "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."}

Revasol Tussin Cherry Flavor Ndc 84379-313-04, 84379-313-16

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information