ADULT LONG LASTING-COUGH RELIEF - dextromethorphan hbr,usp capsule 
Chain Drug Consortium 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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ACTIVE INGREDIENT(S)

Dextromethorphan HBr, USP 15 mg 

PURPOSE

Cough Suppressant 

USE(S)

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

WARNINGS


DO NOT USEYou 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

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.

PREGNANCY/BREASTFEEDING

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.

DIRECTIONS

STORAGE

INACTIVE INGREDIENTS

Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

PRINCIPAL DISPLAY PANEL

CARTON LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for upto 8 hours
Non-drowsy
Non-Narcotic formula

20 softgels

Dex-cdc-ct-20sfg



BOTTLE LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for about 8 hours
Non-Drowsy
Non-Narcotic Formula

20 Softgels

Dex-cdc-bt-20sfg

ADULT LONG LASTING-COUGH RELIEF 
dextromethorphan hbr,usp capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-026
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
GELATIN (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code 26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-026-201 in 1 CARTON
120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/22/2013
Labeler - Chain Drug Consortium LLC (101668460)
Registrant - Chain Drug Consortium LLC (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(68016-026)

Revised: 5/2013
Document Id: 1e92cbc2-8ec7-442e-a6ec-d069080c53fd
Set id: 1e92cbc2-8ec7-442e-a6ec-d069080c53fd
Version: 1
Effective Time: 20130521
 
Chain Drug Consortium LLC