Label: DECONEX DMX- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

  • NDC Code(s): 50991-740-01, 50991-740-02
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 27, 2024

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  • 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 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:

    		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

  • INGREDIENTS AND APPEARANCE
    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)
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