ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS- dextromethorphan hbr capsule, liquid filled

ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS by

Drug Labeling and Warnings

ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, PF Consumer Healthcare Canada ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)

Dextromethorphan HBr, USP 15 mg

PURPOSE

Cough suppressant

USE

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

WARNINGS

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.

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

OTHER INFORMATION

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

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

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM-5 PM EST at 1-800-762-4675

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ADULT

Robitussin LINGERING COLD Long-Acting CoughGels

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves: Cough for up to 8 Hours

Non-Narcotic Formula

Non-Drowsy

For Ages 12 & Over

20 LIQUI-GELS*

*Liquid-Filled Capsules

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

Stop use and ask a doctor if cough lasts more than 7 days.

Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.

For most recent product information, visit www.robitussin.com

LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

INGREDIENTS AND APPEARANCE

ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS 
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8741
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
COCONUT OIL (UNII: Q9L0O73W7L)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (clear red)	Score	no score
Shape	OVAL (oval softgel)	Size	10mm
Flavor		Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8741-20	1 in 1 BLISTER PACK	06/06/2011
1		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/06/2011

Labeler - Richmond Division of Wyeth (829390835)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0031-8741) , LABEL(0031-8741) , PACK(0031-8741)