DECONEX

Dosage form: capsule
Ingredients: Guaifenesin 390mg, Phenylephrine Hydrochloride 10mg
Labeler: Poly Pharmaceuticals
NDC Code: 50991-582

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.

DECONEX CAPSULES

Drug Facts Active ingredients
(in each capsule)

Guaifenesin 390 mg
Phenylephrine HCl 10 mg

PurposeExpectorant
Nasal Decongestant

UsesTemporarily 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 passages

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 capsule every 4 hours, not to
exceed 6 capsules in 24 hours.

Children under
12 years of age:
Consult a physician.




Other informationStore at controlled room temperature between 15°-30°C (59°-86°F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Deconex Capsules are blue-orange capsules imprinted "Deconex" in black ink.

Inactive ingredientsCroscarmellose Sodium, Dicalcium Phosphate Dihydrate, FD&C Blue #1, FD&C Yellow #6, Gelatin, Magnesium Stearate, Maltodextrin, Povidone, Silicon Dioxide, Stearic Acid, and Titanium Dioxide.

Questions? Comments?Call 1-800-882-1041

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

Rev. 11/11

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel for 60 capsules label:

NDC  50991-582-60

DECONEX
CAPSULES


EXPECTORANT · NASAL DECONGESTANT

Each capsule contains:
Guaifenesin..................................390 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 capsules

Rev. 11/11





DECONEX 
guaifenesin, phenylephrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-582
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin390 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Calcium Phosphate, Dibasic, Dihydrate 
Gelatin 
Magnesium Stearate 
Maltodextrin 
Povidone 
Silicon Dioxide 
Stearic Acid 
Titanium Dioxide 
Product Characteristics
Colorblue (blue-orange) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeDeconex
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-582-6060 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/07/2012
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 02/2012
 
Poly Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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