Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID becb4025-b63e-f2ea-9d11-d51fdf4e5c13

Route

ORAL

Published

Effective Date 2025-06-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Chlorpheniramine (2 mg) Dextromethorphan (15 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Lactic Acid, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-01-01

Description

Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg

Purpose

Antihistamine Cough suppressant

Medication Information

Purpose

Antihistamine Cough suppressant

Description

Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 older	20 mL every 6 hours

Do Not Use

•
to sedate a child or 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.

Other Information

•
each 10 mL contains: sodium 6 mg
•
store at 20-25°C (68-77°F)

Inactive Ingredients

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

Additional Information

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

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

Questions Or Comments?

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

Principal Display Panel

Children's

Robitussin

AGES 6 & OVER

Cough & Cold

Long-Acting

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓
Cough Up to 8 Hours
✓
Runny Nose

Alcohol-Free

fruit

punch

flavor

4 FL OZ

(118 ml)

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

Active Ingredients (in Each 10 Ml)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Ask A Doctor Before Use If You Have

•
trouble urinating due to an enlarged prostate gland
•
glaucoma
•
a cough that occurs with too much phlegm (mucus)
•
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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 older	20 mL every 6 hours

Do Not Use (Do not use)

•
to sedate a child or 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.

Other Information (Other information)

•
each 10 mL contains: sodium 6 mg
•
store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

Additional Information

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

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Children's

Robitussin

AGES 6 & OVER

Cough & Cold

Long-Acting

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓
Cough Up to 8 Hours
✓
Runny Nose

Alcohol-Free

fruit

punch

flavor

4 FL OZ

(118 ml)

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

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

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

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
•
a cough that occurs with too much phlegm (mucus)
•
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTIC ACID, UNSPECIFIED FORM", "unii": "33X04XA5AT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 older 20 mL every 6 hours", "Do not use": "• to sedate a child or 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.", "Other information": "• each 10 mL contains: sodium 6 mg • store at 20-25°C (68-77°F)", "Inactive ingredients": "anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural & artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Additional Information": "Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Use dosage cup included", "Questions or comments?": "Call weekdays from 8 AM to 6 PM EST at 1-800-245-1040", "PRINCIPAL DISPLAY PANEL": "Children's Robitussin AGES 6 & OVER Cough & Cold Long-Acting CHLORPHENIRAMINE MALEATE (Antihistamine) DEXTROMETHORPHAN HBr (Cough Suppressant) Relieves: ✓ Cough Up to 8 Hours ✓ Runny Nose Alcohol-Free fruit punch flavor 4 FL OZ (118 ml)", "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", "Active ingredients (in each 10 mL)": "Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg", "Ask a doctor before use if you have": "• trouble urinating due to an enlarged prostate gland • glaucoma • a cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:14.317187 · Updated: 2026-03-14T23:08:54.445441