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°-86° F (15°-30° C)

Inactive ingredients

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

Questions or comments? 1-877-586-7979

Principal Display Panel - 198 mg Label

meijer®

NDC 79481-0300-1

Vapor
Inhaler

Levmetamfetamine

Nasal Decongestant

Temporarily
relieves
nasal
congestion
due to
colds,
hay fever,
and upper
respiratory
allergies

NET WT 0.007 OZ (198 mg)

INHALER

LEVMETAMFETAMINE
levmetamfetamine inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79481-0300
Route of Administration	NASAL

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

Ingredient Name	Strength
Inactive Ingredients
Bornyl acetate (UNII: 213431586X)
Camphor (Synthetic) (UNII: 5TJD82A1ET)
Lavender oil (UNII: ZBP1YXW0H8)
Menthol (UNII: L7T10EIP3A)
Methyl Salicylate (UNII: LAV5U5022Y)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79481-0300-1	1 in 1 BLISTER PACK	09/29/2023
1		198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	09/29/2023

Labeler - Meijer, Inc. (006959555)

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

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Maryland, LLC		829739833	MANUFACTURE(79481-0300)

Drug Facts