Drug Facts

Drug Facts

SPL v11

SPL

SPL Set ID 6afaf85b-bf0c-4c99-acf3-a34f06be20f1

Route

ORAL

Published

Effective Date 2025-05-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (15 mg) Doxylamine (6.25 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 15 mg Doxylamine Succinate, USP 6.25 mg

Purpose

Cough Suppressant Antihistamine

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Purpose

Cough Suppressant Antihistamine

Dosage and Administration

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

Description

Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 mg

Section 44425-7

Other information

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

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 ifcough 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 aretaking sedatives or tranquilizers

Section 51727-6

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

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Purposes

Cough Suppressant

Antihistamine

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.

Additional Information

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

Dist. by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

For most recent product information, visit www.robitussin.com

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel

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)

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 10ml)

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 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

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

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

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 ifcough 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 aretaking sedatives or tranquilizers

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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

Purposes

Cough Suppressant

Antihistamine

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.

Additional Information

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

Dist. by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

For most recent product information, visit www.robitussin.com

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)

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 10ml) (Active ingredients (in each 10mL))

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 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": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "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": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC GLUCONATE", "unii": "U6WSN5SQ1Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings", "44425-7": "Other information each 10 mL contains : sodium 10 mg store at 20–25°C (68–77°F)", "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", "51727-6": "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", "53413-1": "Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-245-1040", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough Suppressant Antihistamine", "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.", "Additional Information": "Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Dist. by: Haleon, Warren, NJ 07059 ©2024 Haleon or licensor. Trademarks owned or licensed by Haleon. For most recent product information, visit www.robitussin.com Pat. Info www.productpats.com Made in Canada", "PRINCIPAL DISPLAY PANEL": "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 8 hours Runny nose Taste the Real Honey TRUE SOURCE CERTIFIED HONEY ✓ 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 10mL)": "Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 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: 2026-02-15T12:06:07.495447 · Updated: 2026-03-14T23:08:44.584027