PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]

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PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]
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NDC 45802-432-62
Set ID 458594e1-8d99-4de3-8923-2fd8ce2fc406
Category HUMAN OTC DRUG LABEL
Packager Padagis Israel Pharmaceuticals Ltd
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves sinus congestion and pressure
    •
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 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

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    symptoms do not improve within 7 days or occur with a fever

    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. (1-800-222-1222)

  • Directions

    adults and children 12 years and over
    •
    take 2 tablets every 4 to 6 hours
    •
    do not take more than 8 tablets in 24 hours

    children ages 6 to 11 years
    •
    take 1 tablet every 4 to 6 hours
    •
    do not take more than 4 tablets in 24 hours

    children under 6 years

    do not use this product in children under 6 years of age
  • Other information

    •
    each tablet contains: calcium 20 mg
    •
    store at 20°-25°C (68°-77°F)
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Sudafed® Congestion active ingredient

    Pseudoephedrine Hydrochloride

    30 mg

    Nasal Decongestant

    Maximum Strength – Non-Drowsy

    Sinus Pressure – Congestion

    24 TABLETS, 30 mg EACH

    Pseudoephedrine HCl – Sinus

    actual size

    Congestion

    Perrigo Pseudoephedrine Hydrochloride image
  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-432
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUND (convex) Size7mm
    FlavorImprint Code L432
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-432-6224 in 1 CARTON10/17/2008
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/17/2008
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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