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 ingredients (in each LiquiCap)

Dextromethorphan Hbr 15 mg

Purpose

Cough Suppressant

Uses temporarily

relieves cough due to minor throat and bronchial irritation 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 cough as occurs with smoking, asthma or emphysema

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 conditions

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

Keep out of reach of children.

Overdose Warning

In case of overdose,get medical help or contact a poison control center right away.

Direction

• * do not take more than 8 liquidgels in any 24 hour period.
• * adults and children 12 years over : take 2 liquidgels every 6 to 8 hours, as needed
• * Children under 12years: ask a doctor

Other information

• * each tablet contains : Store at room temperature

Inactive ingredients

FD &C Red No 40 IH, Polyethylene Glycol , Gelatin, Glycerin, Povidone, Purified water, Sorbitol

PRINCIPAL DISPLAY PANEL - 15mg Tablet Shipper Label

Dextromethorphan Hydrobromide Soft Gelatin Capsules
Each Soft Gelatin Capsules Contains:
Dextromethorphan Hydrobromide USP 15mg

Lot No. :

Mfg. Date :

Exp. Date :

NDC No. : 68210-1530-4

Quantity : 4000 Capsules

Gross Wt. :

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDAAND REGULATIONS THEREUNDER

MANUFACTURED BY:
Marksans Pharma Ltd
Verna, GOA-403722,
India.
Code : GO/DRUGS/515

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS,LLC
225 LINCOLN HWY, STE # 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000; FAX.#2159434039

OMIL059

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1530
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)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1530-4	1 in 1 DRUM
1		4000 in 1 BAG
2	NDC: 68210-1530-6	1 in 1 DRUM
2		6000 in 1 BAG
3	NDC: 68210-1530-8	1 in 1 DRUM
3		8000 in 1 BAG
4	NDC: 68210-1530-1	1 in 1 DRUM
4		10000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/15/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)