Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f22248b7-7abd-4df7-a986-dae357ebe8f1
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)
Inactive Ingredients
Calcium Gluconate Monohydrate Carboxymethylcellulose Calcium Carnauba Wax Corn Syrup Crospovidone, Unspecified Fd&c Red No. 40 Glycerin Mannitol Starch, Corn Dimethicone, Unspecified Sodium Gluconate Sorbitol Sorbitol Solution Sucralose Sucrose Cow Milk

Identifiers & Packaging

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

Description

Active ingredient (in each chewable tablet) Dextromethorphan equivalent to 15 mg dextromethorphan HBr


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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 swalloing
  • 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 to 8 hours, as needed

children under 12 years

do not use

Description

Active ingredient (in each chewable tablet) Dextromethorphan equivalent to 15 mg dextromethorphan HBr

Section 44425-7

Other information

  • each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium 6 mg
  • store at a controlled room temperature 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 useif 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, FD&C red no. 40, 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

Purpose

Cough suppressant

Section 55106-9

Active ingredient (in each chewable tablet)

Dextromethorphan equivalent to 15 mg dextromethorphan HBr

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

Long-Acting Cough

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg

(Cough Suppressant)

FASTrelief ANYWHERE

UP TO 8HRCOUGH RELIEF

10 CHEWABLE TABLETS

Chew tablets completely before swallowing

Berry flavor

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Structured Label Content

Indications and Usage (34067-9)

Use

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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 swalloing
  • 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 to 8 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 6 mg
  • store at a controlled room temperature 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 useif 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, FD&C red no. 40, 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)

Purpose

Cough suppressant

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Dextromethorphan equivalent to 15 mg dextromethorphan HBr

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

Long-Acting Cough

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg

(Cough Suppressant)

FASTrelief ANYWHERE

UP TO 8HRCOUGH RELIEF

10 CHEWABLE TABLETS

Chew tablets completely before swallowing

Berry flavor

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data


Raw Label Data

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