Dicel CD

Dosage form: liquid
Ingredients: Brompheniramine Maleate 2mg in 5mL, Chlophedianol Hydrochloride 12.5mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Centrix Pharmaceutical
NDC Code: 11528-107

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.

Dicel CD Liquid

Drug Facts Active Ingredients                                                      Purpose
(in each 5 mL teaspoonful)

Brompheniramine Maleate 2 mg....................................................Antihistamine
Chlophedianol Hydrochloride 12.5 mg............................................Cough Suppressant
Pseudoephedrine Hydrochloride 30 mg..........................................Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes

Warnings Do not exceed recommended dosage.

Do not use this product
  • 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 physician or pharmacist before taking this product.

Ask a physician before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a physician or pharmacist before use if you aretaking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a physician if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of the reach of children.In case of an accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions Do not exceed recommended dosage.


Adults and children 12 years of age
and over:
2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed
8 teaspoonfuls (40 mL) in 24 hours.
Children 6 to under
12 years of age:
1 teaspoonful (5 mL) every 6 to 8 hours, not to exceed
4 teaspoonfuls (20 mL) in 24 hours.
Children under 6 years of age:
Consult a physician

Other informationStore at 59° - 86° F (15° - 30­° C)

Inactive ingredientsCitric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Call your physician for medial advice.  Serious side effects associated with this product may be reported to this number.
1-866-991-9871
8 am - 5 pm M-F CST




Manufactured for:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242

Product Packaging:Packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 11528-107-16

Dicel CD Liquid

(brompheniramine maleate 2 mg, chlophedianol HCl 12.5 mg, pseudoephedrine HCl 30 mg)

Each teaspoonful (5 mL) for oral administration contains:
Brompheniramine Maleate....................................2 mg
Chlophedianol HCl...........................................12.5 mg
Pseudoephedrine HCl.........................................30 mg

  • Antihistamine
  • Cough Suppressant
  • Nasal Decongestant
Sugar Free/Alcohol Free/Dye Free

CENTRIX
PHARMACEUTICAL, INC.

16 fl oz (473 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

This package not intended for dispensing to the patient.

Manufactured for:
CENTRIX
PHARMACEUTICAL, INC.
Birmingham, AL  35242

Rev. 02/10


Principal display panel and side panel for 118 mL label:

NDC 11528-107-04

Dicel CD Liquid

(brompheniramine maleate 2 mg, chlophendianol HCl 12.5 mg, pseudoephedrine HCl 30 mg)

Each teaspoonful (5 mL) for oral administration contains:
Brompheniramine Maleate...............................2 mg
Chlophedianol HCl......................................12.5 mg
Pseudoephedrine HCl.....................................30 mg

  • Antihistamine
  • Cough Suppressant
  • Nasal Decongestant
Sugar Free/Alcohol Free/ Dye Free

CENTRIX
PHARMACEUTICAL, INC.

4 fl oz (118 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Manufactured for:
CENTRIX
PHARMACEUTICAL, INC.
Birmingham, AL 35242

Rev. 02/10


Principal display panel and side panel for 15 mL label:

NDC 11528-107-75

Dicel CD

(brompheniramine maleate 2 mg, chlophedianol HCl 12.5 mg, pseudoephedrine HCl 30 mg)

Antihistamine/Cough Suppressant/Nasal Decongestant

Each teaspoonful (5 mL) for oral administration contains:
Brompheniramine Maleate............................................2 mg
Chlophedianol HCl...................................................12.5 mg
Pseudoephedrine HCl.................................................30 mg

Sugar Free/Alcohol Free/Dye Free

1/2 fl oz (15 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Manufactured for:
CENTRIX
PHARMACEUTICAL, INC.
Birmingham, AL  35242

Rev. 03/10                                  PROFESSIONAL SAMPLE





















DICEL   CD
brompheniramine maleate, chlophendianol hydrochloride, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11528-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate2 mg  in 5 mL
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11528-107-16473 mL in 1 BOTTLE
2NDC:11528-107-04118 mL in 1 BOTTLE
3NDC:11528-107-756 BOTTLE (BOTTLE) in 1 CARTON
315 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/06/2010
Labeler - Centrix Pharmaceutical (185405367)

Revised: 06/2010
 
Centrix Pharmaceutical

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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