DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

DEXTROMETHORPHAN Hydrobromide by

Drug Labeling and Warnings

DEXTROMETHORPHAN Hydrobromide by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15mg

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
• trouble urinating due to an enlarged prostate gland

Stop use and ask 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 orcontact 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

• 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, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 15 Softgels Bottle Label

COMPARE TO ACTIVE INGREDIENT OF
ROBITUSSIN ® LONG ACTING COUGH GELS ©*

ASSURED™

ADULT LONG LASTING
Cough Relief

Dextromethorphan HBr, 15 mg

• Cough suppressant
• Relieves cough for up to 8 hours
• Non-drowsy / Non-narcotic

15 softgels

AGES 12+

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0005
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	404
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0005-0	1 in 1 CARTON	11/22/2017
1		15 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	11/22/2017

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(68210-0005)