Label: DECONEX IR- guaifenesin and phenylephrine hydrochloride tablet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients
    (in each tablet)

    Guaifenesin 380 mg
    Phenylephrine HCl 10 mg

    Purpose

    Expectorant
    Nasal Decongestant
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  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passage
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  • 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.
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  • 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.


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  • Other information

    Store at controlled room temperature between 15°- 30°C (59°- 86°F).
    Supplied in a tight, light-resistant container with a child-resistant cap.
    Contains color additives including FD&C Yellow No. 5 (tartrazine).
    Deconex IR Tablets are green, oval-shaped, scored tablets, debossed "POLY" bisect "716" on one side, and plain on the other side.
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.
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  • Questions? Comments?

    Call 1-800-882-1041

    Manufactured for:
    Poly Pharmaceuticals
    Quitman, MS  39355
    1 (800) 882-1041

    Rev. 02/12
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  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 60 tablets label:

    NDC 50991-716-60

    DECONEX IR
    TABLETS


    EXPECTORANT · NASAL DECONGESTANT

    Each tablet contains:
    Guaifenesin..............................380 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
    Quitman, MS  39355

    60 tablets

    Rev.  02/12

    Deconex IR Tablets Packaging


    Deconex IR Tablets Packaging


    Deconex IR Tablets Packaging

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  • INGREDIENTS AND APPEARANCE
    DECONEX  IR
    guaifenesin, phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50991-716
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 380 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    Croscarmellose Sodium  
    Hypromelloses  
    Maltodextrin  
    Povidone  
    Silicon Dioxide  
    Cellulose, Microcrystalline  
    Stearic Acid  
    Product Characteristics
    Color green Score 2 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code POLY;716
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50991-716-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/25/2012
    Labeler - Poly Pharmaceuticals (198449894)
    Registrant - Pernix Manufacturing, LLC (078641814)
    Establishment
    Name Address ID/FEI Business Operations
    Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(50991-716)
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