CORFEN DM - chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Cypress Pharmaceutical, Inc.

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 5 mL teaspoonful)

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

Purpose

Antihistamine
Cough Suppressant
Nasal Decongestant

Uses

temporarily 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 now know if your prescription drug contains an
MAOI, ask a doctor or pharmacists 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 are

taking 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 when 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.
Children 6 to under 12 years of age:
1/2 teaspoonful (2.5 mL) every 4-6 hours as needed.
Children under 6 years of age:
Consult a physician.

Other information

Store at 77oF (25oC), excursions permitted; 15o - 30oC (59o - 86oF)

Inactive ingredients

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

Questions? Comments?

1-800-856-4393
M-F: 8:00a.m. - 5:00p.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 PACKAGING

The packaging below represents the labeling currently used.

NDC 60258-238-16

CORFEN-DM Liquid

Antihistamine/Cough Suppressant/Nasal Decongestant

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

DYE FREE / SUGAR FREE
ALCOHOL FREE

Cypress Pharmeutical, 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

Rev. 06/09

Corfen DM Packaging

Corfen DM Packaging


Corfen DM Packaging

Corfen DM Packaging



CORFEN  DM
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-238
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 DescriptionMultilevel Packaging
1NDC:60258-238-16473 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/200308/26/2011

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 08/2011 Cypress Pharmaceutical, Inc.