Cvs Pharmacy, Inc. Tussin Dm Drug Facts

Cvs Pharmacy, Inc. Tussin Dm Drug Facts
SPL v4
SPL
SPL Set ID 6feaf29e-de06-4c94-912c-a76ea2cbd8c1
Route
ORAL
Published
Effective Date 2024-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg) Guaifenesin (20 mg)
Inactive Ingredients
Anhydrous Citric Acid Benzoic Acid Benzyl Alcohol 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 Sorbitol Solution Sucralose Xanthan Gum Acetic Acid Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-20

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Purpose

Cough suppressant Antihistamine


Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep
Purposes

Cough suppressant

Antihistamine

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
  • 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 6 hours

children under 12 years

do not use

Do Not Use
  • to make a child sleepy
  • 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.
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.

Other Information
  • each 20 mL contains: sodium 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

When Using This Product
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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).

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel

DAY & NIGHT COMBO PACK

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

CVS Health®

Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

MAXIMUM STRENGTH

MAXIMUM STRENGTH±

See New Dosing

Nighttime

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

Adult Cough & Antihistamine

Relieves:

• Cough

• Itchy throat

• Runny nose

No added alcohol

Raspberry, Blackberry & Menthol Flavor

For Ages 12 & Over

Dosage cup provided

4 FL OZ (118 mL) + 4 FL OZ (118 mL)

TOTAL 8 FL OZ (236 mL)

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

Active Ingredients (in Each 20 Ml) Daytime

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Active Ingredients (in Each 20 Ml) Nighttime

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep
Purposes

Cough suppressant

Antihistamine

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
  • 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 6 hours

children under 12 years

do not use

Do Not Use
  • to make a child sleepy
  • 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.
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.

Other Information (Other information)
  • each 20 mL contains: sodium 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

DAY & NIGHT COMBO PACK

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

CVS Health®

Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

MAXIMUM STRENGTH

MAXIMUM STRENGTH±

See New Dosing

Nighttime

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

Adult Cough & Antihistamine

Relieves:

• Cough

• Itchy throat

• Runny nose

No added alcohol

Raspberry, Blackberry & Menthol Flavor

For Ages 12 & Over

Dosage cup provided

4 FL OZ (118 mL) + 4 FL OZ (118 mL)

TOTAL 8 FL OZ (236 mL)

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

Active Ingredients (in Each 20 Ml) Daytime (Active ingredients (in each 20 mL) - DAYTIME)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Active Ingredients (in Each 20 Ml) Nighttime (Active ingredients (in each 20 mL) - NIGHTTIME)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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