NDC 50991-740 Deconex Dmx

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 50991-740

NDC Code: 50991-740

Proprietary Name: Deconex Dmx What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
POLY;730
Score: 2

NDC Code Structure

  • 50991 - Poly Pharmaceuticals, Inc.
    • 50991-740 - Deconex

NDC 50991-740-01

Package Description: 100 TABLET in 1 BOTTLE

NDC 50991-740-02

Package Description: 12 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK

NDC Product Information

Deconex Dmx with NDC 50991-740 is a a human over the counter drug product labeled by Poly Pharmaceuticals, Inc.. The generic name of Deconex Dmx is dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Poly Pharmaceuticals, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Deconex Dmx Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROMETHORPHAN HYDROBROMIDE 17.5 mg/1
  • GUAIFENESIN 400 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Poly Pharmaceuticals, Inc.
Labeler Code: 50991
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Deconex Dmx Product Label Images

Deconex Dmx Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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:cough due to minor throat and bronchial irritationhelps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productivenasal congestionreduces 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 emphysemaa cough that occurs with too much phlegm (mucus)heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurcough 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

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.

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 tabletsRev. 06-19

* Please review the disclaimer below.

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