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


Nasal Decongestant


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


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.


Do not exceed recommended dosage.
Adults and children
12 years of age and over:
1 tablet every 4 hours, not to
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

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.

Questions? Comments?

Call 1-800-882-1041

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

Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-716-60



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.  02/12

Deconex IR Tablets Packaging

Deconex IR Tablets Packaging

Deconex IR Tablets Packaging

guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50991-716
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin380 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Silicon Dioxide 
Cellulose, Microcrystalline 
Stearic Acid 
Product Characteristics
ColorgreenScore2 pieces
FlavorImprint Code POLY;716
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-716-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/25/2012
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Pernix Manufacturing, LLC (078641814)
NameAddressID/FEIBusiness Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(50991-716)

Revised: 10/2012
Document Id: 27c3d7bb-1df8-43cb-8344-fcafe4b734cb
Set id: 52e4dd62-0a34-4072-aee4-1afa3d04329d
Version: 2
Effective Time: 20121026
Poly Pharmaceuticals