Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Coconut Oil Gelatin, Unspecified Glycerin Mannitol Polyethylene Glycol, Unspecified Povidone, Unspecified Propyl Gallate Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: R Shape: oval Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-07-15

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 8 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age

adults and children 12 years and over	take 1 capsule (15 mg) every 4 hours, as required
children under 12 years	do not use

Description

Active ingredient (in each liquid-filled capsule) Dextromethorphan HBr, USP 15 mg

Section 44425-7

Other information

store at 20°C-25°C (68°F -77°F)
avoid excessive heat above 40°C (104°F)
protect from light

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 for 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

FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides

Section 53413-1

Questions or comments?

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

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 liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

Made in India

Principal Display Panel

NEW

Robitussin

Cough

Dextromethorphan HBr

(Cough Suppressant)

direct

Actual size

18

Liqui-Gels ^®*

*Liquid filled capsules

L-0630-782-44-UPC_ORG Front Label

Ask A Doctor Before Use If You Have

a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic 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 8 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age

adults and children 12 years and over	take 1 capsule (15 mg) every 4 hours, as required
children under 12 years	do not use

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

store at 20°C-25°C (68°F -77°F)
avoid excessive heat above 40°C (104°F)
protect from light

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 for 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

FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides

Section 53413-1 (53413-1)

Questions or comments?

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

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 liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

Made in India

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Robitussin

Cough

Dextromethorphan HBr

(Cough Suppressant)

direct

Actual size

18

Liqui-Gels ^®*

*Liquid filled capsules

L-0630-782-44-UPC_ORG Front Label

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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