DICEL DM - chlorpheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride tablet, chewable 
Centrix Pharmaceutical

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.

----------

Active ingredients                                                                   

(in each chewable)

Chlorpheniramine Maleate  2mg

Dextromethorphan Hydrobromide 10mg

Pseudoephedrine Hydrochloride  30mg

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 two weeks after stopping the MAOI drug.  If you do no 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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, 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.

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses temporarily relieves these symptoms due to a cold, hay fever or other upper respiratory allergies

Inactive ingredients Acelylated Monoglycerine, Ammonium Glycyrrhizate, Cellulose Acetate, Croscarmellose Sodium, Ethylcellulose, Eudragit E acrylic polymer, FD and C Blue #1 Lake, Flavors, Hydroxypropylmethylcellulose, Hydroxypropylcellulose, Malic Acid, Meltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Lauryl Sulfate, Soy Lecithin, Sucralose, Sugar, Vegetable Oil

Directions


adults and children 12 years of age and over
2 chewables every 4 to 6 hours
children 6 to under 12 years of age
one chewable every 4 to 6 hours
children under 6 years of age
consult a doctor

image of carton


DICEL  DM
chlorpheniramine/dextromethorphan/pseudoephedrine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11528-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED 
CELLULOSE ACETATE 
CROSCARMELLOSE SODIUM 
ETHYLCELLULOSES 
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MALIC ACID 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
LECITHIN, SOYBEAN 
SUCRALOSE 
PALM KERNEL OIL 
SODIUM LAURYL SULFATE 
SUCROSE 
Product Characteristics
ColorpinkScore no score
ShapeBULLETSize25mm
FlavorImprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:11528-106-0220 TABLET, CHEWABLE ( TABLET) in 1 CARTONNone
2NDC:11528-106-442 TABLET, CHEWABLE ( TABLET) in 1 CARTONNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/201005/25/2012

Labeler - Centrix Pharmaceutical (185405367)
Registrant - Elge Inc (610655136)
Establishment
NameAddressID/FEIOperations
Elge Inc610655136manufacture

Revised: 05/2012 Centrix Pharmaceutical