Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 472c5c1f-eb5a-444b-a17e-f0d71007fb15
Route
ORAL
Published
Effective Date 2020-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Description

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


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
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

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

Section 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

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
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

Warnings and Precautions (34071-1)

Warnings

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

Section 55106-9 (55106-9)

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

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

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


Raw Label Data

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