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

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  • POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]

POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]
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NDC 50991-214-01, 50991-214-02
Set ID 739329ae-0b62-4eab-a07d-867b5d3d61e0
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

    Dextromethorphan HBr 20mg
    Guaifenesin 380mg
    Pseudoephedrine HCl 60mg

  • 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 associated with a cold
    • alleviates cough to help you sleep
    • non-narcotic cough suppressant for relief of cough
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • itchy, watery eyes
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose and throat
  • 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 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.

    Ask a doctor before use if you have:

    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus)
    • 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 DM is a yellow, oblong, capsule shaped, scored tablet, debossed POLY 214 on one side and

    blank on the other.

  • Inactive ingredients

    FD&C Yellow #5, 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 50991-214-01

    Poly-Vent DM Tablets

    Cough Suppressant

    Expectorant ● Nasal Decongestant

    100 tablets

    front

    back

  • INGREDIENTS AND APPEARANCE
    POLY-VENT DM 
    dextromethorphan hbr, guaifenesin and pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-214
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN380 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeCAPSULE (Oblong) Size19mm
    FlavorImprint Code POLY214
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-214-0212 in 1 CARTON06/17/2013
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:50991-214-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/17/2013
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United, Inc.172837085manufacture(50991-214)
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