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 2019-01-04

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

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

age		dose
adults and children 12 years and over		take 2 capsules every 6 to 8 hours, as needed
children under 12 years		do not use

Description

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

Principal Display Panel

ADULT

NEW LOOK!

Robitussin ^®

Long-Acting

CoughGels ^®

DEXTROMETHORPHAN HBr

(Cough Suppressant)

UP

TO

8 HR

RELIEF

Non-Drowsy

Formula

For Ages 12 & Over

20

LIQUI-GELS ^®*

*LIQUID FILLED CAPSULES

Section 42229-5

Distributed by: Pfizer, Madison, NJ 07940 USA

Section 44425-7

Other information

store at 20-25°C (68-77°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 1-800-762-4675

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

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

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

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

age		dose
adults and children 12 years and over		take 2 capsules every 6 to 8 hours, as needed
children under 12 years		do not use

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

NEW LOOK!

Robitussin ^®

Long-Acting

CoughGels ^®

DEXTROMETHORPHAN HBr

(Cough Suppressant)

UP

TO

8 HR

RELIEF

Non-Drowsy

Formula

For Ages 12 & Over

20

LIQUI-GELS ^®*

*LIQUID FILLED CAPSULES

Section 42229-5 (42229-5)

Distributed by: Pfizer, Madison, NJ 07940 USA

Section 44425-7 (44425-7)

Other information

store at 20-25°C (68-77°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 1-800-762-4675

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

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)

{"34067-9": "Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.", "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 age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use", "34071-1": "Warnings", "42229-5": "Distributed by: Pfizer, Madison, NJ 07940 USA", "44425-7": "Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light", "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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "50570-1": "Do not use 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.", "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", "53413-1": "Questions or comments? Call weekdays from 9 AM-5 PM EST at 1-800-762-4675", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Cough suppressant", "55106-9": "Active ingredient (in each liquid-filled capsule) Dextromethorphan HBr, USP 15 mg", "PRINCIPAL DISPLAY PANEL": "ADULT NEW LOOK! Robitussin ® Long-Acting CoughGels ® DEXTROMETHORPHAN HBr (Cough Suppressant) UP TO 8 HR RELIEF Non-Drowsy Formula For Ages 12 & Over 20 LIQUI-GELS ® * *LIQUID FILLED CAPSULES", "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"}