NASAL DECONGESTANT INHALER- levmetamfetamine nasal decongestant inhalant 
Aphena Pharma Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use for temporary relief of nasal congestion due to:

Warnings

When using this product

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.

Directions

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

Inactive Ingredients:

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

Questions or comments? 1-877-586-7979

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

_______________________

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 label

nasal inhaler card front

nasal inhaler card back

NASAL DECONGESTANT INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54884-050
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2) LEVMETAMFETAMINE50 mg
Inactive Ingredients
Ingredient NameStrength
BORNYL ACETATE (UNII: 213431586X)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54884-050-011 in 1 BLISTER PACK01/11/2017
1198 in 1 INHALER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2016
Labeler - Aphena Pharma Solutions (829739833)
Registrant - Aphena Pharma Solutions - Maryland, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Maryland, LLC829739833manufacture(54884-050) , pack(54884-050) , label(54884-050)

Revised: 1/2017
Document Id: 1ecbe16e-e5e7-4842-aff7-af45c9a50a76
Set id: 7d734ee3-d29d-41b5-add2-11b90da22040
Version: 1
Effective Time: 20170111
 
Aphena Pharma Solutions