DEXTROMETHORPHAN HYDROBROMIDE- dextromethorphan hydrobromide capsule, liquid filled 
SPIRIT PHARMACEUTICALS,LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dextrmethorphan Hydrobromide Soft Gelatin Capsules

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"

PRINCIPAL DISPLAY PANEL - 15mg Tablet Shipper Label
DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1530
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVALSize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1530-41 in 1 DRUM
14000 in 1 BAG
2NDC:68210-1530-61 in 1 DRUM
26000 in 1 BAG
3NDC:68210-1530-81 in 1 DRUM
38000 in 1 BAG
4NDC:68210-1530-11 in 1 DRUM
410000 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 7/2010
Document Id: 9e5110a5-04b0-4442-b095-d45e04c2266a
Set id: 3e52987b-47d5-4023-8d96-af7cf7fc25b9
Version: 2
Effective Time: 20100726
 
SPIRIT PHARMACEUTICALS,LLC