Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 39468746-e06d-4849-9d06-9af4d14351b0
Route
ORAL
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Sucralose Sucrose Cow Milk Calcium Gluconate Monohydrate Carboxymethylcellulose Calcium Carnauba Wax Corn Syrup Crospovidone, Unspecified D&c Red No. 30 Aluminum Lake Glycerin Mannitol Starch, Corn Dimethicone, Unspecified Sodium Gluconate Sorbitol Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: round Color: purple Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-19
Description

Active ingredients (in each chewable tablet) Dextromethorphan equivalent to 15 mg dextromethorphan HBr Doxylamine succinate 6.25 mg

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
Dosage and Administration

Directions

  • do not take more than 4 doses (8 chewable tablets) in 24-hours, unless directed by a doctor.
  • chew tablets completely before swallowing
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

take 2 chewable tablets every 6 hours, as needed

children under 12 years

do not use
Description

Active ingredients (in each chewable tablet) Dextromethorphan equivalent to 15 mg dextromethorphan HBr Doxylamine succinate 6.25 mg

Section 44425-7

Other information

  • each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium 7 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 50570-1

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.
Section 51727-6

Inactive ingredients

calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

Section 53413-1

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-855-297-3031

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant

Antihistamine

Section 55106-9

Active ingredients (in each chewable tablet)

Dextromethorphan equivalent to 15 mg dextromethorphan HBr

Doxylamine succinate 6.25 mg

Additional Information

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

*Among those with a preference vs. original formulation

PARENTS:

Learn about teen medicine abuse

www.StopMedicineabuse.org

Principal Display Panel

NEW!IMPROVED FLAVOR*

Robitussin

Nighttime Cough DM

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg

(Cough Suppressant)

DOXYLAMINE SUCCINATE 6.25 mg

(Antihistamine)

FAST reliefANYWHERE

Cough, runny nose & sneezing

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

UP TO 8HRCOUGH RELIEF

Berry flavor

When Using This Product
  • 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
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 is chronic such as occurs with smoking, asthma, or chronic bronchitis or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

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

  • do not take more than 4 doses (8 chewable tablets) in 24-hours, unless directed by a doctor.
  • chew tablets completely before swallowing
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

take 2 chewable tablets every 6 hours, as needed

children under 12 years

do not use
Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium 7 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 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients

calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

Section 53413-1 (53413-1)

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-855-297-3031

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each chewable tablet)

Dextromethorphan equivalent to 15 mg dextromethorphan HBr

Doxylamine succinate 6.25 mg

Additional Information

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

*Among those with a preference vs. original formulation

PARENTS:

Learn about teen medicine abuse

www.StopMedicineabuse.org

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW!IMPROVED FLAVOR*

Robitussin

Nighttime Cough DM

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg

(Cough Suppressant)

DOXYLAMINE SUCCINATE 6.25 mg

(Antihistamine)

FAST reliefANYWHERE

Cough, runny nose & sneezing

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

UP TO 8HRCOUGH RELIEF

Berry flavor

When Using This Product (When using this product)
  • 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
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 is chronic such as occurs with smoking, asthma, or 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:20.508395 · Updated: 2026-03-14T23:10:41.056891