Revasol Tussin Dm Max With Honey

Revasol Tussin Dm Max With Honey
SPL v1
SPL
SPL Set ID 30da9255-c93a-84d6-e063-6394a90a7c2a
Route
ORAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Honey Food Yellow 3 Free Acid Water Glycerin Anhydrous Citric Acid Sucralose Sorbitol Solution Xanthan Gum Sodium Benzoate Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

Description

Active ingredients (in each dose, 20 mL) Purpose Dextromethorphan HBr 20 mg..........................Cough Suppressant Guaifenesin 400 mg..........................................Expectorant


Medication Information

Warnings and Precautions

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 wekks 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.

Indications and 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.

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
20 mL

every 4 hours
children under 12 years of age do not use

Description

Active ingredients (in each dose, 20 mL) Purpose Dextromethorphan HBr 20 mg..........................Cough Suppressant Guaifenesin 400 mg..........................................Expectorant

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 50569-3

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 wiht smoking,

asthma, chronic bronchitis, or emphysema

Section 51727-6

Inactive ingredients

citric acid, FD&C Yellow #6, flavors, glycerin, honey,

purified water, propylene glycol, sodium benzoate, sorbitol solution, sucralose.

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

Cough Suppressant

Expectorant

Section 55106-9

Active ingredients (in each dose, 20 mL) Purpose

Dextromethorphan HBr 20 mg..........................Cough Suppressant

Guaifenesin 400 mg..........................................Expectorant

Section 60561-8

Other information

each 20 mL contains: sodium 12 mg

• 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.


Structured Label Content

Indications and Usage (34067-9)

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.

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
20 mL

every 4 hours
children under 12 years of age do not use

Warnings and Precautions (34071-1)

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 wekks 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.

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 50569-3 (50569-3)

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 wiht smoking,

asthma, chronic bronchitis, or emphysema

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C Yellow #6, flavors, glycerin, honey,

purified water, propylene glycol, sodium benzoate, sorbitol solution, sucralose.

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)

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each dose, 20 mL) Purpose

Dextromethorphan HBr 20 mg..........................Cough Suppressant

Guaifenesin 400 mg..........................................Expectorant

Section 60561-8 (60561-8)

Other information

each 20 mL contains: sodium 12 mg

• 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.


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Raw Label Data

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