DECONEX DMX- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DECONEX DMX TABLETS

Drug Facts

Active ingredients (in each tablet)

Dextromethorphan HBr 17.5 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

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

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 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 15°- 30° C (59°- 86° F).

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

Deconex DMX Tablets are orange, oblong, capsule-shaped, scored tablets, debossed "POLY" bisect "730" on one side and blank on the other side.

Inactive ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Hypromellose, Maltodextrin, Povidone, Silicified Microcrystalline Cellulose, and Stearic Acid.

Questions? Comments?

Call 1-800-882-1041.

Manufactured for:

Poly Pharmaceuticals

Huntsville, AL

1(800) 882-1041

Rev: 06/19

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 100 tablets label:

NDC 50991-740-01



DECONEX DMX

TABLETS

COUGH SUPPRESSANT · EXPECTORANT

NASAL DECONGESTANT

Each tablet contains:

Dextromethorphan HBr........................17.5 mg

Guaifenesin......................................400 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
Huntsville, AL

100 tablets

Rev. 06-19

labelback

DECONEX  DMX
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE17.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScore2 pieces
ShapeCAPSULESize17mm
FlavorImprint Code POLY;730
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-740-0212 in 1 CARTON06/01/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50991-740-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2019
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff31a90-4a6e-a4ce-e063-6394a90acf07
Set id: 8aab8e5c-1633-2e5a-e053-2a95a90adcc5
Version: 5
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.