NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]

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NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]
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NDC 0536-3607-35
Set ID 775f97c0-6f82-49a8-82ac-f1a73920c3ec
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug Facts

    Pseudoephedrine Hydrochloride 30 mg

  • Purpose

    Nasal Congestant

  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily restores freer breathing through the nose
  • 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 and 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 use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with 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 oldertake 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
    children ages 6 to 12 yearstake 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
    children under 6 yearsdo not use

  • Other information

    • store at room temperature
  • Inactive ingredients

    Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    *Rugby Laboratories is not affiliated with the owner of the registered trademark Sudafed®

    SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

    Distributed by:

    Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    Re-order No. 370277

    Rev. 03/17 R-29

  • PRINCIPAL DISPLAY PANEL

    Rugby®

    Compare to active ingredient in Sudafed®

    NDC 0536-3607-35

    Nasal Decongestant

    Pseudoephedrine HCl 30 mg

    Temporarily relieves nasal congestion due to cold & allergies without drowsiness

    24 tablets

    1004 label

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3607
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 1004
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-3607-351 in 1 CARTON10/29/2012
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/29/2012
    Labeler - Rugby Laboratories (079246066)
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