CORFEN DM

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 4mg in 5mL, Dextromethorphan Hydrobromide 15mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Cypress Pharmaceutical, Inc.
NDC Code: 60258-520

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.

CORFEN-DM LIQUID

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 10 mg

PurposeAntihistamine
Cough Suppressant
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

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 doctor or pharmacist before taking this product

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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 mellitus

Ask a doctor 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 doctor 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.
  • new symptoms occur

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

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions Do not exceed 6 doses in a 24 hour period.
Adults and children
12 years of age
and over:



1 teaspoonful (5 mL)
every 4-6 hours
as needed. Do not
exceed 8 teaspoons
in 24 hours, or as
directed by a doctor.
Children 6 to
under 12 years
of age:




1/2 teaspoonful
(2.5 mL) every 4-6
hours as needed.
Do not exceed
4 teaspoons in
24 hours, or as
directed by a doctor.
Children under
6 years of age:
Consult a physician.


Other informationStore at 77°F (25°C), excursions permitted; 15°- 30°C (59°- 86°F)

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

Questions? Comments? 1-800-856-4393
M-F:  8:00 a.m. - 5:00 p.m. CT
Serious side effects associated with use of this product may be reported to this number.

Manufactured for:
Cypress Pharmaceutical, Inc.
Madison, MS  39110

Product PackagingThe packaging below represents labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60258-520-16

CORFEN-DM
Liquid


Antihistamine/
Cough Suppressant/
Nasal Decongestant

Each teaspoonful (5 mL) for oral administration contains:
Chlorpheniramine Maleate....................4 mg
Dextromethorphan HBr.......................15 mg
Phenylephrine HCl.............................10 mg

DYE FREE / SUGAR FREE
ALCOHOL FREE

CYPRESS
PHARMACEUTICAL, INC.

16 fl oz (473 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 with
a child-resistant cap.

This bottle is not to be dispensed to the consumer.

Mfg. for:  Cypress Pharmaceutical, Inc.
Madison, MS  39110

L705 Rev. 05/11





CORFEN  DM
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60258-520-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/08/2011
Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 06/2011
 
Cypress Pharmaceutical, Inc.

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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