DECONEX DM

Dosage form: capsule
Ingredients: Dextromethorphan Hydrobromide 15mg, Guaifenesin 390mg, Phenylephrine Hydrochloride 10mg
Labeler: Poly Pharmaceuticals
NDC Code: 50991-583

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 DM CAPSULES

Drug Facts Active ingredients
(in each capsule)

Dextromethorphan HBr 15 mg
Guaifenesin 390 mg
Phenylephrine HCl 10 mg

PurposeCough Suppressant
Expectorant
Nasal Decongestant

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • 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 fro 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 last 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 DM Capsules are purple-yellow capsules imprinted "Deconex DM" in black ink.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Inactive ingedientsCroscarmellose Sodium, Dicalcium Phosphate Dihydrate, FD&C Blue #1, FD&C Red #3, FD&C Yellow #5, 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 and side panel for 60 capsules label:

NDC 50991-583-60

DECONEX DM
CAPSULES

COUGH SUPPRESSANT · EXPECTORANT
NASAL DECONGESTANT


Each capsule contains:
Dextromethorphan HBr............................15 mg
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  DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-583
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg
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
Colorpurple (purple-yellow) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeDeconex;DM
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-583-6060 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/08/2012
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 03/2012
 
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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