Levmetamfetamine

Manufacturer
Meijer, Inc. | Aphena Pharma Solutions - Maryland, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:32

Label at a glance#

ProductLevmetamfetamine
Active ingredientLevmetamfetamine
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (per inhaler)

OTC - ACTIVE INGREDIENT SECTION

Levmetamfetamine 50 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Use

INDICATIONS & USAGE SECTION

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • 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 SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 198 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 198 mg Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0300-1Levmetamfetamine1 in 1 BLISTER PACKINHALANT12
79481-0300-1Levmetamfetamine198 in 1 INHALERINHALANT1982

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0300LEVMETAMFETAMINE INHALANT [MEIJER, INC.]2Current NDC, 2 package rows20241225_d11e916f-90a6-4099-bf83-75f2dfbd6266.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-030079481-0300-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
ndc (package): 79481-0300-1
ndc (product): 79481-0300
ndc11 (package): 79481030001
spl id: 45fcb42f-4b54-4b42-b371-1f421690dff8
spl set id: d11e916f-90a6-4099-bf83-75f2dfbd6266

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.