COUGH AND CONGESTION DM - dextromethorphan and guaifenesin capsule, liquid filled 
Agile Pharmachem

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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Chest and Cough Congestion

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Purpose

Cough Suppressant

Expectorant

Uses

Directions

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information

Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Questions or Comments

Toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4e88b254-figure-01

Cough and Congestion DM,

NDC:58805-007-75  25*300 Softgel Liquid filled

COUGH AND CONGESTION DM 
dextromethorphan and guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (Light) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code 601
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58805-007-757500 in 1 CAPSULE
11 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/08/2015
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

Revised: 11/2015
Document Id: 4e88b254-c0b1-48bf-9ca5-b13a22118204
Set id: 1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e
Version: 1
Effective Time: 20151110
 
Agile Pharmachem