NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

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NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-3330-10, 0498-3330-25, 0498-3330-50, 0498-3331-10, 0498-3331-25, 0498-3331-50
Set ID 3314b12f-78a0-47d7-91b9-56289179bfe2
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active Ingredient

    Phenylephrine HCl 5 mg

  • Purpose

    Nasal decongestant

  • Uses

    Temporarily relieves

    • nasal congestion due to:the common cold, hay fever, or other respiratory allergies
    • sinus congestion and pressure.
  • Warnings

    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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a health professional before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness
    • dizziness
    • sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast feeding

    ask a health professional

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center immediately

  • Directions

    • adults and children 12 years of age and over:
    • take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years, consult a doctor
  • Other information

    • store at room temperature
    • Tamper Evident Packets
    • do not use if open or torn
  • Inactive ingredients

    colloidal silica, croscarmellose sodium, D and C Red # 27 Lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc

  • Questions or comments?

    1-800-430-5490

  • Package Label

    Sinus relief 250

  • Honeywell Sinus Decongestant

    Sinus decongestant

  • INGREDIENTS AND APPEARANCE
    NORTH SINUS DECONGESTANT 
    phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-3330
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Red) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code FR4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3330-10100 in 1 BOTTLE, UNIT-DOSE06/10/2012
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-3330-25250 in 1 BOX, UNIT-DOSE06/10/2012
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-3330-50500 in 1 BOX, UNIT-DOSE06/10/2012
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/10/2012
    SINUS DECONGESTANT 
    phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-3331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Red) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code FR4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3331-10100 in 1 BOTTLE09/18/2018
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-3331-25250 in 1 BOX09/18/2018
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-3331-50500 in 1 BOX09/18/2018
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/18/2018
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-3330, 0498-3331)
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