Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f9999875-3433-4052-a628-39539d373216
Route
ORAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Doxylamine (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Lactic Acid, Unspecified Form Honey Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum Zinc Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-27
Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Purpose

Cough Suppressant Expectorant

Medication Information

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 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 tube
Purposes

Cough suppressant

Antihistamine

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
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 –

Cough Suppressant

Expectorant

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 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours
Other Information
  • each 10 mL contains:sodium 10 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Other Information –
  • each 10 mL contains:sodium 11 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

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

Children’s

Robitussin

Honey

This dynamic duo combines the great taste of natural honey with the effective cough relief of Robitussin you trust to help your child feel better.

Made with Real Honey

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Questions Or Comments?

call weekdays from 9 AM to 5 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
Questions Or Comments? –

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Principal Display Panel –

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • Chest congestion
  • Mucus
  • Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

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)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 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 Honey Nighttime Cough Dm

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

  • Cough up to 8hours
  • Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Honey Day Night Value Pack

Value Pack

Day Night

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • Chest congestion
  • Mucus
  • Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

  • Cough up to 8hours
  • Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

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 tube
Purposes

Cough suppressant

Antihistamine

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
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 –

Cough Suppressant

Expectorant

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 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours
Other Information (Other information)
  • each 10 mL contains:sodium 10 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Other Information – (Other information –)
  • each 10 mL contains:sodium 11 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

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

Children’s

Robitussin

Honey

This dynamic duo combines the great taste of natural honey with the effective cough relief of Robitussin you trust to help your child feel better.

Made with Real Honey

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Questions Or Comments? (Questions or comments?)

call weekdays from 9 AM to 5 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
Questions Or Comments? – (Questions or comments? –)

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Principal Display Panel –

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • Chest congestion
  • Mucus
  • Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

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))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 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 Honey Nighttime Cough Dm (Principal Display Panel – Children’s Robitussin Honey Nighttime Cough DM)

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

  • Cough up to 8hours
  • Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Honey Day Night Value Pack

Value Pack

Day Night

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • Chest congestion
  • Mucus
  • Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

  • Cough up to 8hours
  • Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:53.172448 · Updated: 2026-03-14T23:13:05.198485