DEXTROMETHORPHAN HYDROBROMIDE

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1530

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.

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"

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1530
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
POVIDONE 
SORBITOL 
WATER 
GLYCERIN 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1530-41 BAG (BAG) in 1 DRUM
14000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
2NDC:68210-1530-61 BAG (BAG) in 1 DRUM
26000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
3NDC:68210-1530-81 BAG (BAG) in 1 DRUM
38000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
4NDC:68210-1530-11 BAG (BAG) in 1 DRUM
410000 CAPSULE, LIQUID FILLED (CAPSULE) 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: 07/2010
 
SPIRIT PHARMACEUTICALS,LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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