VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [WALGREENS ]

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VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [WALGREENS ]
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NDC 0363-0564-50, 0363-0564-53
Set ID 77924474-ccc7-497b-9168-91490bcfadfc
Category HUMAN OTC DRUG LABEL
Packager Walgreens
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? 1-800-WALGREENS (1-800-926-4733)

    TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

    DISTRIBUTED BY Walgreen Co.

    200 Wilmot RD, Deerfield, IL 60015 USA

    100% SATISFACTION GUARANTEED

    walgreens.com Made in the USA BCWG 01I Rev. 04/15 , BCWG03 Rev. 4/15

  • Principal Display Panel – 3 Inhaler Carton

    VALUE SIZE

    NDC 0363-0564-53
    Contains 3 of NDC 0363-0564-50

    Walgreens

    Vapor Inhaler

    LEVMETAMFETAMINE / NASAL DECONGESTANT

    NASAL DECONGESTANT

    3 inhalers

    NET WT 0.007 OZ (198 mg) PER INHALER

    TOTAL NET WT 0.021 0Z (594 mg)

    Principal Display Panel – 3 Inhaler Carton
  • INGREDIENTS AND APPEARANCE
    VAPOR INHALER 
    levmetamfetamine nasal decongestant inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0564
    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:0363-0564-501 in 1 BLISTER PACK07/01/2016
    1198 in 1 INHALER; Type 0: Not a Combination Product
    2NDC:0363-0564-533 in 1 BLISTER PACK07/01/2016
    2198 in 1 INHALER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2016
    Labeler - Walgreens (008965063)
    Registrant - Aphena Pharma Solutions-Maryland, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions-Maryland, LLC829739833manufacture(0363-0564) , pack(0363-0564) , label(0363-0564)
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