Label: LEVMETAMFETAMINE 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 July 27, 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? 1-877-586-7979

  • Principal Display Panel - 198 mg Label

    meijer®

    NDC 79481-0300-1

    Vapor
    Inhaler

    Levmetamfetamine

    Nasal Decongestant

    Temporarily
    relieves
    nasal
    congestion
    due to
    colds,
    hay fever,
    and upper
    respiratory
    allergies

    NET WT 0.007 OZ (198 mg)

    INHALER

    Principal Display Panel - 198 mg Label
  • INGREDIENTS AND APPEARANCE
    LEVMETAMFETAMINE 
    levmetamfetamine inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0300
    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:79481-0300-11 in 1 BLISTER PACK09/29/2023
    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 finalpart34109/29/2023
    Labeler - Meijer, Inc. (006959555)
    Registrant - Aphena Pharma Solutions - Maryland, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Maryland, LLC829739833MANUFACTURE(79481-0300)
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