RUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [A-S MEDICATION SOLUTIONS]

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RUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [A-S MEDICATION SOLUTIONS]
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NDC 50090-0226-0
Set ID 403f5679-f1ad-4e84-962d-3ad1964960b1
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each teaspoonful)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves nasal congestion due to

    • common cold
    • hay fever or other respiratory allergies
  • Warnings

    Do not exceed recommended dosage.

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever

    Ask a doctor before use if you have

    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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.

    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 enclosed dosage cup only. Do not use any other device.
    adults & children 12 years & over2 teaspoonfuls
    children 6 to under 12 years1 teaspoonful
    children under 6 yearsdo not use
  • Other information

    • store at 20°-25°C (68°-77°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?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories
    17177 N Laurel Park Drive, Suite 233,
    Livonia, MI, 48152

  • HOW SUPPLIED

    Product: 50090-0226

    NDC: 50090-0226-0 118 mL in a BOTTLE

  • Pseudoephedrine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    RUGBY   NASAL DECONGESTANT
    pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0226(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)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    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:50090-0226-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/26/1999
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0226)
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