Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4029eccd-5443-4ae2-9232-2a1d922798f8
Route
ORAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Dextrose, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum Lactic Acid, Unspecified Form Sorbitol

Identifiers & Packaging

Pill Appearance
Color: purple Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-12
Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Purpose

Antihistamine Cough suppressant

Medication Information

Purpose

Antihistamine Cough suppressant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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
Purposes

Cough Suppressant

Expectorant

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
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

age

dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and over

20 mL every 4 hours
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.

Purposes –

Antihistamine

Cough suppressant

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

age

dose

children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and over

20 mL every 6 hours
Other Information
  • each 20 mL contains:sodium 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

Other Information –
  • each 10 mL contains:sodium 6 mg
  • store at 20-25°C (68-77°F)
Questions Or Comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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
Inactive Ingredients –

anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? –

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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 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.

Active Ingredients (in Each 10 Ml)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 200 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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Principal Display Panel – Children’s Robitussin Cough & Chest

Children’s

Robitussin

FOR AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

BETTER TASTING!*

Great Grape Taste

grapeflavor

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Nighttim E Cough Dm

Children’s

Robitussin

AGES 6 & OVER

Nighttime Cough DM

Long-Acting

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr

(Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-Free

fruit punchflavor

4 FL OZ (118 mL)

Additional Information – Children’s Robitussin Day & Night Cough Relief Value Pack

TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

Do not take both products within 6 hours of each other.

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough – plus relieves other cold symptoms.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Children’s Robitussin Day & Night Cough Relief Value Pack

DAY & NIGHT

COUGH RELIEF

VALUE PACK

Children’s Robitussin

AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

grapeflavor

4 FL OZ (118 mL)

AGES 6 & OVER

Nighttime Cough Long-Acting DM

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-free

fruit punchflavor

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
Purposes

Cough Suppressant

Expectorant

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
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

age

dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and over

20 mL every 4 hours
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.

Purposes –

Antihistamine

Cough suppressant

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

age

dose

children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and over

20 mL every 6 hours
Other Information (Other information)
  • each 20 mL contains:sodium 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

Other Information – (Other information –)
  • each 10 mL contains:sodium 6 mg
  • store at 20-25°C (68-77°F)
Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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
Inactive Ingredients – (Inactive ingredients –)

anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? – (Questions or comments? –)

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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 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.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

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

Dextromethorphan HBr 20 mg

Guaifenesin 200 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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Principal Display Panel – Children’s Robitussin Cough & Chest

Children’s

Robitussin

FOR AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

BETTER TASTING!*

Great Grape Taste

grapeflavor

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Nighttim E Cough Dm (Principal Display Panel – Children’s Robitussin Nighttim e Cough DM)

Children’s

Robitussin

AGES 6 & OVER

Nighttime Cough DM

Long-Acting

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr

(Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-Free

fruit punchflavor

4 FL OZ (118 mL)

Additional Information – Children’s Robitussin Day & Night Cough Relief Value Pack

TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

Do not take both products within 6 hours of each other.

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough – plus relieves other cold symptoms.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Children’s Robitussin Day & Night Cough Relief Value Pack

DAY & NIGHT

COUGH RELIEF

VALUE PACK

Children’s Robitussin

AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

grapeflavor

4 FL OZ (118 mL)

AGES 6 & OVER

Nighttime Cough Long-Acting DM

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-free

fruit punchflavor

4 FL OZ (118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:42.869149 · Updated: 2026-03-14T23:13:03.799451