Drug Facts

Drug Facts

SPL v10

SPL

SPL Set ID 0b41da13-18a1-4987-ae43-1319bfa27484

Route

ORAL

Published

Effective Date 2024-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (30 mg) Doxylamine (12.5 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 2018-06-25

Description

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant Antihistamine

Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 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
controls the impulse to cough to help you sleep

Section 42229-5

Distributed by: Pfizer, Madison, NJ 07940 USA

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 53414-9

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

Purposes

Cough suppressant

Antihistamine

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
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 mL every 6 hours
children under 12 years	do not use

age

dose

adults and children

12 years and over

20 mL every 6 hours

children under 12 years

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

each 20 ml contains: sodium 21 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

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Questions Or Comments?

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

Principal Display Panel

ADULT

Robitussin

Honey

Nighttime

Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

Controls Cough
Relieves runny nose and sneezing

Taste the

Real Honey

DM

NIGHTTIME

MAX

For Ages 12+

4 FL OZ (118 ml)

62000000211557 - Carton

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 20 Ml)

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 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
controls the impulse to cough to help you sleep

Section 42229-5 (42229-5)

Distributed by: Pfizer, Madison, NJ 07940 USA

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 53414-9 (53414-9)

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

Purposes

Cough suppressant

Antihistamine

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
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 mL every 6 hours
children under 12 years	do not use

age

dose

adults and children

12 years and over

20 mL every 6 hours

children under 12 years

do not use

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 20 ml contains: sodium 21 mg
store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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)

ADULT

Robitussin

Honey

Nighttime

Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

Controls Cough
Relieves runny nose and sneezing

Taste the

Real Honey

DM

NIGHTTIME

MAX

For Ages 12+

4 FL OZ (118 ml)

62000000211557 - Carton

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

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 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": "30", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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 controls the impulse to cough to help you sleep", "42229-5": "Distributed by: Pfizer, Madison, NJ 07940 USA", "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": "Cough suppressant Antihistamine", "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 this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years 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": "each 20 ml contains : sodium 21 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", "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 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org", "Questions or comments?": "call weekdays from 8 AM to 6 PM EST at 1-800-245-1040", "PRINCIPAL DISPLAY PANEL": "ADULT Robitussin Honey Nighttime Cough DM DEXTROMETHORPHAN HBr (Cough Suppressant) DOXYLAMINE SUCCINATE (Antihistamine) MAXIMUM STRENGTH Controls Cough Relieves runny nose and sneezing Taste the Real Honey DM NIGHTTIME MAX For Ages 12+ 4 FL OZ (118 ml) 62000000211557 - Carton", "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 20 mL)": "Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 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: 2026-02-15T12:03:02.524829 · Updated: 2026-03-14T23:02:53.135799