Label: DECONEX IR- guaifenesin and phenylephrine hcl tablet

  • NDC Code(s): 50991-736-02, 50991-736-90
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 9, 2024

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

  • SPL UNCLASSIFIED SECTION

    Deconex IR

    Drug Facts

  • Active ingredients

    Guaifenesin 385 mg

  • Purpose

    Expectorant

  • Active ingredients

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal Decongestant

  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

    • helps loosen phlegm and thin bronchial secretions to make coughs more productive
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • Warnings

    Do not exceed recommended dosage.

    A persistent cough may be a sign of a serious  condition. If cough persists for more than 1 week,  tends to recur, or is accompanied by fever, rash, or  persistent headache, consult a doctor.

    Ask a doctor before use if you have

    • a persistent or chronic cough such as occurs  with smoking, asthma, chronic bronchitis, or  emphysema, or if cough is accompanied by  excessive phlegm
    • heart disease
    • high blood  pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the  prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur

    Ask a doctor or pharmacist before use

    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.

    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:

    Adults and children 12 years of age and older: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

    Children age 6 to 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours or as directed by a doctor.

    Children 6 years of age and younger: Consult a physician.

  • Other information

    Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

    Deconex IR Tablets are a green, oval, scored tablet debossed POLY 716 on one side, plain on the other.

  • Inactive ingredients

    FD&C Yellow No. 5, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

    Manufactured for:
    Poly Pharmaceuticals
    Huntsville, AL 35763
    (800) 882-1041
    Rev. 06/16

  • PRINCIPAL DISPLAY PANEL

    NDC 50991-736-90
    Deconex IR
    Tablets
    90 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 50991-736-90
Deconex IR 
Tablets
90 Tablets

  • INGREDIENTS AND APPEARANCE
    DECONEX IR 
    guaifenesin and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-736
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN385 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code POLY;716
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-736-0212 in 1 CARTON08/08/2016
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50991-736-901 in 1 CARTON08/08/2016
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/08/2016
    Labeler - Poly Pharmaceuticals, Inc. (198449894)