POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]

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POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]
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NDC 50991-212-01
Set ID ce0d8c45-446a-4df4-a36b-5000ba69d30d
Category HUMAN OTC DRUG LABEL
Packager Poly Pharmaceuticals, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each tablet)
    Guaifenesin 380mg

    Pseudoephedrine HCl 60 mg

  • Purpose

    Expectorant

    Nasal Decongestant

  • Uses

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

    • helps loosen phlegm and thin bronchial secretions to make coughs more productive
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose and 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.

    Do not 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.

    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

    Stop use and ask a doctor if:

    • nervousness, dizziness, or sleeplessness 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

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
    Children age 6 to under 12 years of age:½ tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
    Children 2 to under 6 years of age:Consult a doctor.
  • Other information

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

    Poly Vent IR Tablets are a blue, oval, scored tablet debossed POLY 212 on one side, plain on the other.

  • Inactive ingredients

    FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

  • Questions? Comments?

    Call 1-800-882-1041.

    Manufactured for:
    Poly Pharmaceuticals
    Quitman, MS 39355
    (800) 882-1041 Rev. 04/13

  • PRINCIPAL DISPLAY PANEL

    NDC 50991-212-01

    Poly-Vent IR Tablets

    Expectorant ● Nasal Decongestant

    100 tablets

    front

    back

  • INGREDIENTS AND APPEARANCE
    POLY-VENT IR 
    guaifenesin and pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN380 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code POLY212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-212-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2013
    2NDC:50991-212-026 in 1 CARTON06/11/2013
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/11/2013
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United, Inc.172837085manufacture(50991-212)
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