477 - tussin dm

477 - tussin dm
SPL v3
SPL
SPL Set ID 7a2f8d48-3123-4c37-b238-bd7cc4242bb7
Route
oral
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
anhydrous citric acid glycerin propylene glycol water sodium benzoate sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-07-23

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg (In each 5mL)


Medication Information

Purpose

Cough Suppressant

Expectorant

Directions

• do not take more than 6 doses in any 24 hour period

• this adult strength product is not intended for use in children under 12 years of age

• measure only with dosing cup provided

• keep dosing cup with product

• TSP=teaspoon • mL=milliliter • dose as follows:

Age

Dose

adults and children

12 years and over

10 mL (2 Teaspoonfuls) every 4 hours

children under 12 years

do not use

Other Information

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

• alcohol-free

• see bottom panel for lot number and expiration date.

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive Ingredients

Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.

Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg (In each 5mL)

Principal Display Panel
Tussin Label
Tussin Carton
Use(s)

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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.

Questions/comments

Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

(In each 5mL)

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema


Structured Label Content

Purpose

Cough Suppressant

Expectorant

Directions

• do not take more than 6 doses in any 24 hour period

• this adult strength product is not intended for use in children under 12 years of age

• measure only with dosing cup provided

• keep dosing cup with product

• TSP=teaspoon • mL=milliliter • dose as follows:

Age

Dose

adults and children

12 years and over

10 mL (2 Teaspoonfuls) every 4 hours

children under 12 years

do not use

Other Information (Other information)

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

• alcohol-free

• see bottom panel for lot number and expiration date.

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.

Principal Display Panel
Tussin Label
Tussin Carton
Use(s)

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Do Not Use (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.

Questions/comments (Questions/Comments)

Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

(In each 5mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You (Ask a doctor before use if you)

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema


Advanced Ingredient Data


Raw Label Data

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