FDA.reportPublic FDA data

Nasal Decongestant Inhaler

Manufacturer
Aphena Pharma Solutions | Aphena Pharma Solutions - Maryland, LLC
Effective date
2017-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:34

Label at a glance#

ProductNasal Decongestant Inhaler
Active ingredientLEVMETAMFETAMINE
Label structure12 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

Storage and handling

​this inhaler is effective for a minimum of 3 months after first use keep inhaler tightly closed store at 59 ​o -86 ​o ​F (15 o - 30 o C)

Label contents#

Full prescribing information#

Active ingredient (per inhaler)

OTC - ACTIVE INGREDIENT SECTION

Levmetamfetamine 50 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Use for temporary relief of nasal congestion due to:

INDICATIONS & USAGE SECTION

  • the common cold
  • hay fever or upper respiratory allergies

When using this product

OTC - DO NOT USE 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 over2 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 ageask a doctor
children under 2 years of agedo not use

Other Information

STORAGE AND HANDLING SECTION

  • ​this inhaler is effective for a minimum of 3 months after first use
  • keep inhaler tightly closed
  • store at 59​o-86​o​F (15o- 30oC)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Questions or comments? 1-877-586-7979

OTC - QUESTIONS SECTION

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

Distributed & Manufactured by: Aphena Pharma Solutions

7978 Industrial Park Road, Easton, MD 21601 USA

www.aphenapharma.com

Made in the USA BCAPS01 Rev. 01/17, LAAPS01 Rev. 01/17

PRINCIPAL DISPLAY PANEL - Vapor Inhaler

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​

_______________________

NDC 54884-050-01

Aphena Pharma Solutions

Nasal Decongestant Inhaler

Levmetamfetamine

_______________________

Levmetamfetamine 50mg - Nasal Decongestant

Use for temporary relief of nasal decongestion

due to:

• the common cold

• hay fever or upper respiratory allergies

Net Wt 0.007 OZ (198 mg) Per Inhaler See Drug Facts

vapor inhaler labelvapor inhaler label

nasal inhaler card frontnasal inhaler card front

nasal inhaler card backnasal inhaler card back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54884-050-012020-01-31C16284748780-19d75b9d0-c7d8-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54884-050-01Nasal Decongestant Inhaler198 in 1 INHALERINHALANT1981
54884-050-01Nasal Decongestant Inhaler1 in 1 BLISTER PACKINHALANT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54884-050NASAL DECONGESTANT INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [APHENA PHARMA SOLUTIONS]1Legacy NDC, 2 package rows20170119_7d734ee3-d29d-41b5-add2-11b90da22040.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54884-05054884-050-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LEVMETAMFETAMINEY24T9BT2Q2ACTIB
BORNYL ACETATE213431586XIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
LAVENDER OILZBP1YXW0H8IACT
MENTHOLL7T10EIP3AIACT
METHYL SALICYLATELAV5U5022YIACT

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
1ecbe16e-e5e7-4842-aff7-af45c9a50a767d734ee3-d29d-41b5-add2-11b90da220402017-01-11WarningsExact identifier
spl id: 1ecbe16e-e5e7-4842-aff7-af45c9a50a76
spl set id: 7d734ee3-d29d-41b5-add2-11b90da22040

Reported adverse events (FAERS/openFDA)#

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