CONEX- dexbrompheniramine maleate, pseudoephedrine liquid

Conex by

Drug Labeling and Warnings

Conex by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tsp.)

Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine

Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant

PURPOSE

Uses:

• Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
• Helps decongest sinus openings and sinus passages
• Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
• Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.
  

WARNINGS

Warnings:

• Do not use if you are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.
  

DO NOT USE

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

Ask a doctor before use if you have

•  heart disease
• high blood pressure
• thyroid disese
• diabetes
• glucoma
• difficulty in urination due to the enlargement of the prostate gland.

When using this product

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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever.
  

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a Health Professional before use.

DOSAGE & ADMINISTRATION

Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

• Age: Dose
• Adults and children 12 years of age and over: take two teaspoonfuls (10 mL) every 4 to 6 hours
• Children 6 to under 12 years of age: take one teaspoonful (5 mL) every 4 to 6 hours
• Children under 6 years of age: ask a doctor

INDICATIONS & USAGE

Other Information:

• Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
• Do not use if there is evidence of tampering
• WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
  

INACTIVE INGREDIENT

Inactive Ingredients: aspartame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONEX 
dexbrompheniramine maleate, pseudoephedrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-802-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2007

Labeler - Llorens Pharmaceutical International Division (037342305)