DICEL - chlorpheniramine maleate 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.

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Drug Facts

Active ingredients                                                                   

(in each chewable)

Chlorpheniramine Maleate  2mg

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium restricted diet
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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

When using this product

  • do not exceed recommended dosage
  • may cause excitability especially in children
  • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleeplessness occurs
  • symptoms do not improve within 7 days, or are accompanied by fever

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

Nasal Decongestant

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

  • Runny nose, sneezing, itching of the nose or throat, and itching watery eyes
  • nasal congestion

Directions

  • do not take more than 4 doses in 24 hours

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


Acetylatated Monoglycerine, Ammonium Glycyrrhizate, Croscarmellose Sodium, Ethylcellulose, Eudtagit E acrylic polymer, FD and C Red #40 Lake, Flavors, Fructose, Hydroxypropylcellulose, Hydroxypropylmethylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Gluconate, Sodium Lauryl Sulfate, Soy Lecithin, Sucralose, Sugar, Vegetable Oil

image of carton

DICEL  
chlorpheniramine/pseudoephedrine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11528-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE 
CROSCARMELLOSE SODIUM 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
LECITHIN, SOYBEAN 
SUCRALOSE 
PALM KERNEL OIL 
SODIUM LAURYL SULFATE 
SUCROSE 
Product Characteristics
ColorpinkScoreno score
ShapeBULLETSize25mm
FlavorImprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11528-101-0220 in 1 CARTON
2NDC:11528-101-442 in 1 CARTON
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/FEIBusiness Operations
Elge Inc610655136manufacture(11528-101)

Revised: 12/2013
 
Centrix Pharmaceutical