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DECONEX (Poly Pharmaceuticals)

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CAPSULE 60 CAPSULE in 1 BOTTLE (50991-582-60) Label Information

Complete DECONEX Information

  • Drug Facts

    Active ingredients
    (in each capsule)

    Guaifenesin 390 mg
    Phenylephrine HCl 10 mg

    PurposeExpectorant
    Nasal Decongestant

  • 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 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 capsule every 4 hours, not to
    exceed 6 capsules in 24 hours.

    Children under
    12 years of age:
    Consult a physician.





  • 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.

    Deconex Capsules are blue-orange capsules imprinted "Deconex" in black ink.

  • Inactive ingredients

    Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, FD&C Blue #1, FD&C Yellow #6, Gelatin, Magnesium Stearate, Maltodextrin, Povidone, Silicon Dioxide, Stearic Acid, and Titanium Dioxide.

  • Questions? Comments?

    Call 1-800-882-1041

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

    Rev. 11/11

  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel for 60 capsules label:

    NDC  50991-582-60

    DECONEX
    CAPSULES


    EXPECTORANT · NASAL DECONGESTANT

    Each capsule contains:
    Guaifenesin..................................390 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 capsules

    Rev. 11/11

    Deconex Capsules Packaging

    Deconex Capsules Packaging


    Deconex Capsules Packaging


  • INGREDIENTS AND APPEARANCE
    DECONEX 
    guaifenesin, phenylephrine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-582
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 390 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP)  
    Gelatin (UNII: 2G86QN327L)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Povidone (UNII: FZ989GH94E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color blue (blue-orange) Score no score
    Shape CAPSULE Size 22mm
    Flavor Imprint Code Deconex
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50991-582-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/07/2012
    Labeler - Poly Pharmaceuticals (198449894)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    Name Address ID/FEI Business Operations
    Great Southern Laboratories 056139553 manufacture