NASAL DECONGESTANT INHALER- levmetamfetamine nasal decongestant inhalant

Nasal Decongestant Inhaler by

Drug Labeling and Warnings

Nasal Decongestant Inhaler by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions, Aphena Pharma Solutions - Maryland, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use for temporary relief of nasal congestion due to:

• the common cold
• hay fever or upper respiratory allergies

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.

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 Information

• ​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:

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

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NDC: 54884-050-01

Aphena Pharma Solutions

Nasal Decongestant Inhaler

Levmetamfetamine

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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

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT INHALER 
levmetamfetamine nasal decongestant inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54884-050
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2)	LEVMETAMFETAMINE	50 mg

Inactive Ingredients
Ingredient Name	Strength
BORNYL ACETATE (UNII: 213431586X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54884-050-01	1 in 1 BLISTER PACK	01/11/2017
1		198 in 1 INHALER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2016

Labeler - Aphena Pharma Solutions (829739833)

Registrant - Aphena Pharma Solutions - Maryland, LLC (829739833)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Maryland, LLC		829739833	manufacture(54884-050) , pack(54884-050) , label(54884-050)