FDA.reportPublic FDA data

Deconex DMX Tablets

Manufacturer
Poly Pharmaceuticals, Inc. | TG United
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:45:13

Label at a glance#

ProductDeconex DMX
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Deconex DMX

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 17.5 mg
Guaifenesin 385 mg
Phenylephrine HCl 10 mg

Purpose (in each tablet)

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50991-738-90
Deconex DMX
Tablets
90 Tablets

PRINCIPAL DISPLAY PANEL NDC 50991-738-90 Deconex DMX Tablets 90 TabletsPRINCIPAL DISPLAY PANEL NDC 50991-738-90 Deconex DMX Tablets 90 Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-738-90EA - Each50991-7380b68d0a7-defc-44d4-a859-94d61132bda212016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-73850991-738-02, 50991-738-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efbb6f70-7102-0914-e053-2a95a90a60ceb209b034-3eb4-4069-b2ae-bb39876ccc4f2022-12-13WarningsExact identifier
spl set id: b209b034-3eb4-4069-b2ae-bb39876ccc4f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.