Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 44feee2f-25bc-48d4-8e13-db1d9daaaa90
Route
ORAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Dextrose, Unspecified Form Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sucralose Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-01
Description

Dextromethorphan HBr, USP 30 mg Doxylamine Succinate, USP 12.5 mg

Purpose

Cough suppressant Antihistamine

Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr, USP 30 mg Doxylamine Succinate, USP 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 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
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 14 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

Additional Information

Do Not Use if foil seal is missing or broken.

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

Principal Display Panel

ADULT

Robitussin

MAXIMUM STRENGTH

Nighttime

Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVE

cough relief

DM

NIGHTTIME

MAX

For Ages 12 & Over

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 20 Ml)

Dextromethorphan HBr, USP 30 mg

Doxylamine Succinate, USP 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 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
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 14 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

Additional Information

Do Not Use if foil seal is missing or broken.

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin

MAXIMUM STRENGTH

Nighttime

Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVE

cough relief

DM

NIGHTTIME

MAX

For Ages 12 & Over

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

Dextromethorphan HBr, USP 30 mg

Doxylamine Succinate, USP 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:42.538346 · Updated: 2026-03-14T23:13:18.140905