CONEX- dexbrompheniramine maleate, pseudoephedrine hcl tablet

Conex by

Drug Labeling and Warnings

Conex by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each film coated tablet)                         Purpose

Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine

Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant

PURPOSE

Uses

• Temporarily relieves nasal congestion due to the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.

WARNINGS

Warnings:

Ask a doctor before you use if you are

• taking sedatives or tranquilizers.

Ask your doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• 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 doctor if

• nervousness, dizziness or sleepiness occur
• symptoms do not improve withing 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.

DO NOT USE

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 MAOI;

ask your doctor or pharmacist before taking this product.

DOSAGE & ADMINISTRATION

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

• Adults and children 12 years of age and over: Take one tablet; every 4 to 6 hours
• Children 6 to under 12 years of age: 1/2 tablet; 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 celsius (68 - 77 degree fahrenheit); excursions permitted to

15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal

under cap. Do not use if there is evidence of tampering.

INACTIVE INGREDIENT

Inactive Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Sodium Starch Glycolate type B, Purified Water, Red iron Oxide, Yellow Iron Oxide, Titanium Dioxide.

QUESTIONS

Questions or Comments?                 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONEX 
dexbrompheniramine maleate, pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-702
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	LLORENS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-702-60	60 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 PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)