Label: RUGBY NASAL DECONGESTANT NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid

  • 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 October 6, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each teaspoonful [TSP])

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves nasal congestion due to

    • common cold
    • hay fever
    • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

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

    • you get nervous, dizzy or sleepless
    • 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.

  • Directions

    • take every 4-6 hours
    • do not take more than 4 doses in 24 hours
    • use only with enclosed dose cup. Do not use with any other device.
    adults & children 12 years and over2 TSP
    children 6 to under 12 years1 TSP
    children under 6 yearsdo not use
  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from light
  • Inactive ingredients

    artificial raspberry flavor, citric acid, FD&C red #40, glycerin, methylparaben, purified water, saccharin sodium, sodium benzoate, sorbitol solution

  • Questions or comments?

    Call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Mfd. for:
    Rugby Laboratories, Inc.
    Duluth, Georgia 30097

  • PRINCIPAL DISPLAY PANEL

    NDC 68258-8000-04

    NDC 68258-8000-04

    NASAL DECONGESTANT
    LIQUID

    Pseudoephedrine HCl 30 mg

    TEMPORARILY RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES WITHOUT DROWSINESS

    •SATISFACTION GUARANTEED•

    4 fl oz
    (118 mL)

  • INGREDIENTS AND APPEARANCE
    RUGBY NASAL DECONGESTANT  NASAL DECONGESTANT
    pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68258-8000(NDC:0536-1850)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Methylparaben (UNII: A2I8C7HI9T)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Raspberry (UNII: 4N14V5R27W)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68258-8000-4118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/26/1999
    Labeler - Dispensing Solutions, Inc. (066070785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785relabel, repack
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