Label: VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH- 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 February 9, 2023

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  • Active ingredient

    per inhaler:

    Levmetamfetamine 50mg

  • 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

  • Principal Display Panel - 198 mg Blister Pack Label

    NDC 36800-294-07

    +TopCare® health™

    Vapor
    Inhaler

    OUR PHARMACISTS
    RECOMMENDED

    LEVMETAMFETAMINE - NASAL DECONGESTANT

    Temporary Relief of Nasal
    Congestion Due to:

    • Colds • Hay Fever

    • Upper Respiratory Allergies

    NET WT 0.007 OZ (198mg)

    Principal Display Panel - 198 mg Blister Pack Label
  • Principal Display Panel - 198 mg Inhaler Label

    NDC 36800-294-07

    +TopCare®
    health™

    Vapor
    Inhaler

    LEVMETAMFETAMINE - NASAL DECONGESTANT

    NET WT 0.007 OZ (198mg)

    Principal Display Panel - 198 mg Inhaler Label
  • INGREDIENTS AND APPEARANCE
    VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH
    levmetamfetamine inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-294
    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:36800-294-071 in 1 BLISTER PACK02/19/2021
    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 finalpart34102/19/2021
    Labeler - Topco Associates LLC (006935977)
    Registrant - Aphena Pharma Solutions MD, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(36800-294)
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