DECONEX IR - guaifenesin and phenylephrine hydrochloride tablet
Poly Pharmaceuticals

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.

----------

Drug Facts

Active ingredients
(in each tablet)
Guaifenesin 380 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
nasal congestion
reduces swelling of nasal passage

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 cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

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. A persistent cough may be a sign of a serious condition.
new symptoms occur

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

Keep out of 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:	1 tablet every 4 hours, not exceed 6 tablets in 24 hours.
Children 6 to under 12 years of age:	1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
Children under 6 years of age:	Consult a physician.

Other information

Store at controlled room temperature between 15°- 30°C (59°- 86°F).
Supplied in a tight, light-resistant container with a child-resistant cap.
Contains color additives including FD&C Yellow No. 5 (tartrazine).
Deconex IR Tablets are green, oval-shaped, scored tablets, debossed "POLY" bisect "716" on one side, and plain on the other side.

Inactive ingredients

Croscarmellose Sodium, FD&C Blue #1 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, Hypromellose, Maltodextrin, Povidone, Silicon Dioxide, Siliconized Microcrystalline, and Stearic Acid.

Questions? Comments?

Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355
1 (800) 882-1041

Rev: 11/11

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-716-60

DECONEX IR
TABLETS

EXPECTORANT · NASAL DECONGESTANT

Each tablet contains:
Guaifenesin..............................380 mg
Phenylephrine HCl......................10 mg

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Distributed by:
Poly Pharmaceuticals
Quitman, MS 39355

60 tablets

Rev: 11/11

DECONEX IR
guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50991-716
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	380 mg
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium
Hypromelloses
Maltodextrin
Povidone
Silicon Dioxide
Cellulose, Microcrystalline
Stearic Acid

Product Characteristics
Color	green	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	POLY;716
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50991-716-60	60 TABLET ( TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/25/2012

Labeler - Poly Pharmaceuticals (198449894)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	manufacture

Revised: 02/2012 Poly Pharmaceuticals