Label: NASAL DECONGESTANT- pseudoephedrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • 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 exceed recommended dose

    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 in a dry place at 15° – 30°C (59° – 86°F).
  • Inactive ingredients

    calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

  • Questions or comments?

    1-800-616-2471

  • 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

    Indianapolis, IN 46268

    www.majorpharmaceuticals.com

    Re-order No. 370277

    Rev. 08/22 R-29

  • PRINCIPAL DISPLAY PANEL

    Rugby®

    Compare to active ingredient in Sudafed® Sinus Congestion*

    NDC 0536-3607-35

    Nasal Decongestant

    Pseudoephedrine HCl 30 mg

    Temporarily relieves nasal congestion due to colds & allergies without drowsiness

    24 tablets

    Rugby 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)  
    TALC (UNII: 7SEV7J4R1U)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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 DrugM01210/29/2012
    Labeler - Rugby Laboratories (079246066)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!