VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, DG HEALTH- levmetamfetamine inhalant

Vapor Inhaler by

Drug Labeling and Warnings

Vapor Inhaler by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc., Aphena Pharma Solutions MD, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

per inhaler:

Levmetamfetamine 50mg

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?

1-888-309-9030

Principal Display Panel - 198 mg Blister Pack Label

DG™|health

Temporarily
Relieves Stuffy
Nose

NDC: 55910-265-24

Vapor Inhaler

Levmetamfetamine...Nasal Decongestant

TEMPORARY RELIEF FROM
NASAL CONGESTION

COLDS | HAY FEVER

UPPER RESPIRATORY ALLERGIES

SEE DRUG FACTS

TAMPER EVIDENT:
Use only if perforated
tube label is intact.

NET WT 0.007 OZ

(198 mg)

Principal Display Panel - 198 mg Inhaler Label

DG™|health

NDC: 55910-265-24

Vapor Inhaler

Levmetamfetamine...Nasal Decongestant

NET WT 0.007 OZ (198 mg)

INGREDIENTS AND APPEARANCE

VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, DG HEALTH
levmetamfetamine inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-265
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: 55910-265-24	1 in 1 BLISTER PACK	02/23/2021
1		198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/23/2021

Labeler - Dolgencorp Inc. (068331990)

Registrant - Aphena Pharma Solutions MD, LLC (829739833)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions MD, LLC		829739833	MANUFACTURE(55910-265)