Vapor Inhaler

Manufacturer
Topco Associates LLC | Aphena Pharma Solutions MD, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:28

Label at a glance#

ProductVapor Inhaler levmetamfetamine nasal decongestant, TopCare health
Active ingredientLevmetamfetamine
Label structure9 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

OTC - ACTIVE INGREDIENT SECTION

per inhaler:

Levmetamfetamine 50mg

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

OTC - DO NOT USE SECTION

  • 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

SPL UNCLASSIFIED 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 Blister Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Blister Pack Label

Principal Display Panel - 198 mg Inhaler Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-294-07

+TopCare®
health™

Vapor
Inhaler

LEVMETAMFETAMINE - NASAL DECONGESTANT

NET WT 0.007 OZ (198mg)

Principal Display Panel - 198 mg Inhaler Label
Principal Display Panel - 198 mg Inhaler Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-294-072023-02-13C16284748780-1f386c64a-1d8d-0266-e053-dadaa90a7c1aDrug Facts
36800-294-072023-01-30C16284748780-1f386c64a-1d8d-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-294-07Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health198 in 1 INHALERINHALANT1983
36800-294-07Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health1 in 1 BLISTER PACKINHALANT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-294VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH (LEVMETAMFETAMINE) INHALANT [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241225_8f995561-759a-4837-a82a-640417a6f889.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-29436800-294-07

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
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
ndc (package): 36800-294-07
ndc (product): 36800-294
ndc11 (package): 36800029407
spl id: 5ff33a27-60d6-4de1-be38-9b45f1f56209
spl set id: 8f995561-759a-4837-a82a-640417a6f889

Reported adverse events (FAERS/openFDA)#

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