DEXPHEN W/ CODEINE - codeine phosphate, dexchlorpheniramine maleate and phenylephrine hydrochloride liquid 
Breckenridge Pharmaceutical, Inc.

----------

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Purpose
*
(Warning: May be habit-forming)
Codeine Phosphate* 10 mgAntitussive (Cough Suppressant)
Dexchlorpheniramine Maleate 1 mgAntihistamine
Phenylephrine Hydrochloride 5 mgNasal Decongestant

Uses

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

Warnings

Do not exceed recommended dosage.

Do not use this product

Do not take this product, unless directed by a doctor before use if you have

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

When using the product

Stop use and ask a doctor if

If pregnant or breastfeeding, ask a health professional before use.

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

Directions

Do not exceed recommended dosage.

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

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious effects for your child.

Other information

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from freezing. All substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Inactive ingredients

Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, Sorbitol.

Questions or comments?

Call 1-800-367-3395

Manufactured for:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 51991-729-16

Dexphen™ w/C
Liquid

Each 5 mL (one teaspoonful) for
oral administration contains:
Codeine Phosphate*10 mg
*(Warning: May be habit-forming)
Dexchlorpheniramine Maleate1 mg
Phenylephrine Hydrochloride5 mg

Antitussive • Decongestant
Antihistamine

SUGAR FREE • ALCOHOL FREE
DYE FREE • GLUTEN FREE

DO NOT USE IF FOIL SEAL UNDER
CAP IS BROKEN OR MISSING

Net Contents:
16 fl. oz. (1 pint) 473 mL

Principal Display Panel - 473 mL Bottle Label

DEXPHEN W/ CODEINE 
codeine phosphate, dexchlorpheniramine maleate, and phenylephrine hydrochloride   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)51991-729
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate10 mg  in 5 mL
Dexchlorpheniramine Maleate (Dexchlorpheniramine) Dexchlorpheniramine Maleate1 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Propylene Glycol 
Water 
Saccharin Sodium 
Sodium Benzoate 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-729-16473 mL In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/10/2010

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Deltex Pharmaceuticals019851778MANUFACTURE
Revised: 10/2010Breckenridge Pharmaceutical, Inc.