NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]

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  • NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]

NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]
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NDC 42254-359-10
Set ID 83ae6177-afbb-477f-a5ff-64d48960ffef
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA075153
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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 mg

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves 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 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 1 tablet every 12 hours
    • do not take more than 2 tablets in 24 hours
    children under 12 yearsdo not use this product in children under 12 years of age
  • Other information

    • each tablet contains: calcium 45 mg
    • store at 20° - 25°C (68° - 77°F) in a dry place
    • protect from light
    • do not use if blister unit is broken or torn
    • see carton end panel for lot number and expiration date
    • this product meets the requirements of USP Drug Release Test 3
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Sudafed® 12 Hour Caplets active ingredient

    Nasal Decongestant

    MAXIMUM STRENGTH

    NON-DROWSY

    SINUS

    pseudoephedrine hydrochloride extended release tablets, 120 mg

    Long-Acting Nasal Decongestant

    12-Hour

    Sinus pressure

    Congestion

    Pseudoephedrine HCl

    120 mg each

    *(Capsule-shaped Tablets)

    Nasal Decongestant 120mg

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-359(NDC:24385-054)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code L054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-359-101 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515308/12/1999
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    NameAddressID/FEIBusiness Operations
    PSS World Medical, Inc.791528623REPACK(42254-359)
    Establishment
    NameAddressID/FEIBusiness Operations
    STAT RX USA LLC786036330REPACK(42254-359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785RELABEL(42254-359) , REPACK(42254-359)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCRIPT PAK964420108RELABEL(42254-359) , REPACK(42254-359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals, Inc.362861077REPACK(42254-359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distirbutors Corp.118802834RELABEL(42254-359) , REPACK(42254-359)
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