ROBITUSSIN LONG-ACTING COUGHGELS- dextromethorphan hydrobromide capsule, liquid filled

ROBITUSSIN LONG-ACTING COUGHGELS by

Drug Labeling and Warnings

ROBITUSSIN 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

PURPOSE

Purpose

Cough suppressant

INDICATIONS & USAGE

Use

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

WARNINGS

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 for 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.

DOSAGE & 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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Label

ADULT

Robitussin®

Long-Acting CoughGels®

DEXTROMETHORPHAN HBr (Cough Suppressant)

Non-Drowsy
Formula

UP
TO
8 HR
RELIEF

20
LIQUI-GELS®*
*Liquid-Filled Capsules

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

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

INGREDIENTS AND APPEARANCE

ROBITUSSIN LONG-ACTING COUGHGELS 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8743
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 BLUE NO. 1 (UNII: H3R47K3TBD)
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	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8743-20	1 in 1 CARTON	01/04/2019
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	01/04/2019

Labeler - Richmond Division of Wyeth (829390835)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0031-8743) , LABEL(0031-8743) , PACK(0031-8743)