VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CARDINAL HEALTH (LEADER)]

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VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CARDINAL HEALTH (LEADER)]
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NDC 49781-045-98
Set ID 7a0a343c-efa5-4e66-80e0-2e6b56b86ff4
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health (Leader)
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient (per inhaler)

    Levmetamfetamine 50 mg

  • Purpose

    Nasal decongestant

  • Use for temporary relief of nasal congestion due to:

    • the common cold
    • hay fever or upper respiratory allergies
  • Warnings

  • When using this product

    • do not exceed recommended dosage
    • temporary burning, stinging, sneezing, or increased nasal discharge may occur
    • use of this container by more than one person may spread infection
    • do not use for more than 7 days
    • Use only as directed
    • frequent or prolonged use may cause nasal congestion to recur or worsen
  • Stop use and ask a doctor if

    symptoms persist

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
    • do not use more often than every 2 hours
    adults and children 12 years of age and over2 inhalations in each nostril

    children 6 to under 12 years of age

    (with adult supervision)

    		1 inhalation in each nostril
    children under 6 years of ageask a doctor
    children under 2 years of agedo not use

  • Other Information

    • ​this inhaler is effective for a minimum of 3 months after first use
    • keep inhaler tightly closed
    • store at 59​o-86​o​F (15o- 30oC)
  • Inactive Ingredients:

    bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

  • Questions or comments? 1-877-586-7979

    TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

    *This product is not manufactured or distributed by Procter & Gamble, distributor

    of Vicks® VapoInhaler®.  Vicks® VapoInhaler® is a trademark of Procter & Gamble​.

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

    www.myleader.com  1-800-200-6313   CIN 4914057

    Made in the USA    BCLE01   Rev. 06/13

  • PRINCIPAL DISPLAY PANEL - Vapor Inhaler

    ​Leader

    NDC 49781-045-98

    Compare to Vicks® VapoInhaler®

    active ingredient*

    Nasal Decongestant

    Vapor Inhaler

    Levmetamfetamine • Nasal Decongestant

    Temporary Relief of Nasal Congestion due to:

    •Colds • Hay Fever

    •Upper Respiratory Allergies

    Satisfaction Guaranteed

    NET WT .007 oz (198 mg)

    image description

  • INGREDIENTS AND APPEARANCE
    VAPOR INHALER 
    levmetamfetamine nasal decongestant inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-045
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2) LEVMETAMFETAMINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    BORNYL ACETATE (UNII: 213431586X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-045-981 in 1 BLISTER PACK
    1198 in 1 INHALER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2014
    Labeler - Cardinal Health (Leader) (097537435)
    Registrant - Aphena Pharma Solutions-New York, LLC (078573647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions-New York, LLC078573647manufacture(49781-045) , pack(49781-045) , label(49781-045)
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