Label: NASAL DECONGESTANT- pseudoephedrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2021

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  • Active ingredient (in each tablet)

    •
    Pseudoephedrine HCl 30 mg
  • Purpose

    •
    Nasal Congestant
  • Use(s)

    •
    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 stoppin 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

    •
    diabetes
    •
    high blood pressure
    •
    heart disease
    •
    thyroid disease
    •
    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 older 

     take 2 tablets every 4 to 6 hours;
    do not take more than 8 tablets in
    24 hours 

     children ages 6 to 12 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
  • Other information

    •
    store at room temperature 15º-30ºC (59º-86ºF)
  • 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

  • Principal Display Panel

    Rugby®

    compare to Sudafed®

    Decongestant active ingredient*

    NDC 63187-344-24

    Nasal Decongestant

    pseudoephedrine HCl 30 mg

    Temporarily relieves:

    • nasal congestion due to cold & allergies withoout drowsiness

    24 tablets, 30 mg each

    TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

    Rev 04/13

    R-29

    DISTRIBUTED BY:
    Rugby Laboratories
    31778 Enterprise Drive
    Livonia, MI 48150
    www.rugbylaboratories.com

    Repackaged by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

    63187-344-24
  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-344(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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    ACER SACCHARUM POLLEN (UNII: V38QUQ7861)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 1004
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-344-241 in 1 CARTON03/03/2014
    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 - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-344)
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