Deconex DMX by Poly Pharmaceuticals, Inc. / TG United Deconex DMX Tablets

Deconex DMX by

Drug Labeling and Warnings

Deconex DMX by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc., TG United. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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Deconex DMX Tablets

Deconex DMX

Drug Facts

Active ingredients

Dextromethorphan HBr 17.5 mg
Guaifenesin 385 mg
Phenylephrine HCl 10 mg

Purpose (in each tablet)

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

Temporarily 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 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:

½ 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

FD&C Yellow No. 6, D&C Yellow No. 10, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Questions? Comments?

Call 1-800-882-1041.

Manufactured for:
Poly Pharmaceuticals
Huntsville, AL 35763
1(800) 882-1041 Rev. 06/16

PRINCIPAL DISPLAY PANEL

NDC: 50991-738-90
Deconex DMX
Tablets
90 Tablets

DECONEX DMX 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-738
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	17.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	385 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	orange	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	POLY;730
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-738-02	12 in 1 CARTON	08/08/2016	03/25/2020
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50991-738-90	1 in 1 CARTON	08/08/2016	03/25/2020
2		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/08/2016	03/25/2020

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(50991-738)

Revised: 3/2020

Document Id: a2198b60-6917-862e-e053-2a95a90a835d

34390-5

Set id: b209b034-3eb4-4069-b2ae-bb39876ccc4f

Version: 5

Effective Time: 20200330