Label: VAPOR INHALER- levmetamfetamine nasal decongestant inhalant

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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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 over 2 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 age ask a doctor
    children under 2 years of age do not use
  • Other information

    • this inhaler is effective for a minimum of 3 months after first use
    • keep inhaler tightly closed
    • store at 59°-86° F (15°-30° C)
  • Inactive ingredients

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

  • Questions or comments?

    800-935-2362

  • Principal Display Panel – 198 mg Blister Pack Label

    NDC 63868-267-01

    QC®

    QUALITY
    CHOICE

    Vapor Inhaler

    Nasal Decongestant

    Levmetamfetamine
    Temporary Relief of
    Nasal Congestion Due to
    Colds,
    Hay Fever
    Upper Respiratory Allergies

    NET WT 0.007 OZ (198 mg)

    Principal Display Panel – 198 mg Blister Pack Label
  • 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 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2014
    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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