Label: VAPOR INHALER- levmetamfetamine nasal decongestant inhalant

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 13, 2023

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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 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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