cvs pharmacy, inc. tussin dm drug facts

cvs pharmacy, inc. tussin dm drug facts
SPL v4
SPL
SPL Set ID 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca
Route
oral
Published
Effective Date 2025-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg)
Inactive Ingredients
acetic acid anhydrous citric acid carboxymethylcellulose sodium, unspecified fd&c blue no. 1 fd&c red no. 40 glycerin menthol, unspecified form polyethylene glycol, unspecified propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2018-05-04 Until 2025-05-31

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg


Medication Information

Uses
  • 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
Purpose

Cough suppressant Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other Information
  • each 20 mL contains: sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

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 Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding,

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 right away (1-800-222-1222).

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel

CVS Health®

Compare to the active ingredients in Robitussin® Maximum Strength Cough + Chest Congestion DM

MAXIMUM STRENGTH

MAXIMUM STRENGTH± FOR MUCUS RELIEF

See New Dosing

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

Adult Cough & Chest Congestion

Relieves:

• Cough

• Chest congestion

• Mucus

No added alcohol

Raspberry & Menthol Flavor

For Ages 12 & Over

Dosage cup provided

±Maximum strength claim based on maximum daily dose of active ingredients.

Actual Bottle Size on Side Panel

4 FL OZ (118 mL)


Structured Label Content

Uses
  • 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
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other Information (Other information)
  • each 20 mL contains: sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Purposes

Cough suppressant

Expectorant

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 Or Comments? (Questions or comments?)

1-800-719-9260

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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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 right away (1-800-222-1222).

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

CVS Health®

Compare to the active ingredients in Robitussin® Maximum Strength Cough + Chest Congestion DM

MAXIMUM STRENGTH

MAXIMUM STRENGTH± FOR MUCUS RELIEF

See New Dosing

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

Adult Cough & Chest Congestion

Relieves:

• Cough

• Chest congestion

• Mucus

No added alcohol

Raspberry & Menthol Flavor

For Ages 12 & Over

Dosage cup provided

±Maximum strength claim based on maximum daily dose of active ingredients.

Actual Bottle Size on Side Panel

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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