MedPath

Vapor Inhaler

Drug Facts

Approved
Approval ID

69059828-25dc-444f-bab4-0ec5325e5b91

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Geiss, Destin & Dunn, Inc.

DUNS: 076059836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levmetamfetamine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-281
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Levmetamfetamine
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (6)

LevmetamfetamineActive
Quantity: 50 mg in 1 1
Code: Y24T9BT2Q2
Classification: ACTIB
Bornyl acetateInactive
Code: 213431586X
Classification: IACT
Camphor (Synthetic)Inactive
Code: 5TJD82A1ET
Classification: IACT
Lavender oilInactive
Code: ZBP1YXW0H8
Classification: IACT
MentholInactive
Code: L7T10EIP3A
Classification: IACT
Methyl SalicylateInactive
Code: LAV5U5022Y
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Principal Display Panel - 198 mg Blister Pack Label

GOODSENSE**®**

NDC 50804-281-07

Nasal Decongestant

Vapor Inhaler

Levmetamfetamine • Nasal Decongestant

Temporary Relief of
Nasal Congestion due to:

*Colds • Hay Fever *Upper Respiratory Allergies

NET WT
.007 oz (198 mg)

Compare to active ingredient of
Vicks
®
* Vapolnhaler****®**

100%
SATISFACTION
GUARANTEED

Principal Display Panel - 198 mg Blister Pack Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/8/2021

Use

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/8/2021

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/8/2021

Purpose

Nasal decongestant

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/8/2021

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/8/2021

Questions or comments?

1-866-696-0957

WARNINGS SECTION

LOINC: 34071-1Updated: 3/8/2021

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/8/2021

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 3/8/2021

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)

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