Label: VICKS VAPOINHALER- levmetamfetamine inhalant 

  • NDC Code(s): 37000-686-01
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/10

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (per inhaler)

    Levmetamfetamine 50 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    temporarily relieves nasal congestion due to:

    • a cold
    • hay fever or other upper respiratory allergies
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  • 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.

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  • Directions

    • the product delivers into 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 and over 2 inhalations in each nostril
    children 6 to under 12 years (with adult supervision) 1 inhalation in each nostril
    children 2 to under 6 years ask a doctor
    children under 2 years do not use
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  • Other information

    • store at room temperature
    • keep inhaler tightly closed
    • this inhaler is effective for a minimum of 3 months after first use
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  • Inactive ingredients

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

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  • Questions?

    1-800-873-8276

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati OH 45202.

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  • PRINCIPAL DISPLAY PANEL - 204 mg Inhaler Blister Pack

    TAMPER EVIDENT: Do not use if printed
    inhaler wrap is broken or missing.

    VICKS®

    VapoInhaler
    Levmetamfetamine…Nasal Decongestant

    FAST RELIEF FROM
    NASAL CONGESTION

    • Colds  • Hay Fever
    • Allergies

    With Soothing
    Vicks Vapors

    See Drug Facts

    Net Wt. 0.007 OZ (204 mg)

    Approximate Inhaler Location
    (F.P.O.)

    Principal Display Panel - 204 mg Inhaler Blister Pack
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  • INGREDIENTS AND APPEARANCE
    VICKS  VAPOINHALER
    levmetamfetamine inhalant
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-686
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Levmetamfetamine (Levmetamfetamine) Levmetamfetamine 0.245 mg  in 1000 mg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-686-01 1 in 1 BLISTER PACK
    1 204 mg in 1 INHALER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/09/2009
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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