DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]

DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]
PDF | XML

NDC 50991-535-01
Set ID 55fffc1d-8449-4c28-a391-c6f60dd85622
Category HUMAN OTC DRUG LABEL
Packager Poly Pharmaceuticals, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    DurafluTablets

    Rev. 08/15

    Drug Facts

  • Active Ingredients

    Acetaminophen 325 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 200 mg
    Pseudoephedrine HCl 60 mg

  • Purpose

    Pain Reliever
    Antitussive
    Expectorant
    Nasal Decongestant

  • Temporarily relieves

    • minor aches and pains
    • fever
    • headache
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • nasal congestion due to the common cold
  • Warnings

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take:

    • More than 3,000 mg of acetaminophen in 24 hrs;
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    • Do not Exceed recommended dosage

    KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use this product

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • 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

    ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating ■ due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use

    if you are taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition

  • Directions

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctor
    Children under 12 years of age½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

    When using this product do not exceed recommended dosage.

  • Other information

    Store at 20°- 25° Celsius (68° – 77° Fahrenheit) as defined in the (USP/NF). Dispense in tight, light-resistant container.

  • Inactive ingredients

    magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions or comments?

    800-882-1041

    Manufactured For:
    Poly Pharmaceuticals, Inc.
    Huntsville, AL 35763

    Rev. 08/15

  • PRINCIPAL DISPLAY PANEL

    NDC 50991-535-01
    DURAFLU™
    Expectorant/ Nasal Decongestant
    Antitussive/Pain Reliever
    100 Tablets

    NDC 50991-535-01
DURAFLU™
Expectorant/ Nasal Decongestant
Antitussive/Pain Reliever
100 Tablets

  • INGREDIENTS AND APPEARANCE
    DURAFLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize20mm
    FlavorImprint Code PE;723
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-535-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2015
    2NDC:50991-535-026 in 1 CARTON10/01/2015
    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 finalpart34110/01/2015
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United172837085manufacture(50991-535)