FDA Label for Levmetamfetamine

View Indications, Usage & Precautions

Levmetamfetamine Product Label

The following document was submitted to the FDA by the labeler of this product Meijer, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

Otc - Stop Use



Stop use and ask a doctor if symptoms persist


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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 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


* Please review the disclaimer below.