Drug Facts
Active ingredients (in each tablet)
Dextromethorphan HBr 17.5 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Deconex Tablet
FDA Label NDC 50991-740
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Deconex (NDC 50991-740). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
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
Label (Newdmx)
Back (Dmxback)
* Please review the disclaimer below.
