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
Purpose

Antihistamine Cough suppressant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 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

Antihistamine Cough suppressant

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
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

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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
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 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
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
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

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
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 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