VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]

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  • VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]

VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]
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Set ID 904b7e21-cce5-4b96-afc1-b36f532f98ac
Category HUMAN OTC DRUG LABEL
Packager C.D.M.A., Inc.
Generic Name
Product Class
Product Number
Application Number
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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 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? 248-449-9300

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile Novi, MI 48376

    Questions: 248-449-9300

    Made in the USA    BCQC01.   Rev. 06/13

  • PRINCIPAL DISPLAY PANEL - Vapor Inhaler

    ​QC®

    Quality Choice

    NDC 63868-267-01

    Vapor Inhaler

    Nasal Decongestant

    Levmetamfetamine | Nasal Decongestant

    Temporary Relief of

    Nasal Congestion due to:

    Colds | Hay Fever

    Upper Respiratory Allergies

    *Compare to the active ingredient in Vicks®

    Vapoinhaler

    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:63868-267
    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:63868-267-011 in 1 BLISTER PACK01/01/2014
    1198 in 1 INHALER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2014
    Labeler - C.D.M.A., Inc. (011920774)
    Registrant - Aphena Pharma Solutions MD, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(63868-267)
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