VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH- levmetamfetamine inhalant

Vapor Inhaler by

Drug Labeling and Warnings

Vapor Inhaler by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, 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

Principal Display Panel - 198 mg Blister Pack Label

NDC: 36800-294-07

+TopCare® health™

Vapor
Inhaler

OUR PHARMACISTS
RECOMMENDED

LEVMETAMFETAMINE - NASAL DECONGESTANT

Temporary Relief of Nasal
Congestion Due to:

Colds Hay Fever

Upper Respiratory Allergies

NET WT 0.007 OZ (198mg)

Principal Display Panel - 198 mg Inhaler Label

NDC: 36800-294-07

+TopCare®
health™

Vapor
Inhaler

LEVMETAMFETAMINE - NASAL DECONGESTANT

NET WT 0.007 OZ (198mg)

INGREDIENTS AND APPEARANCE

VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH
levmetamfetamine inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-294
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: 36800-294-07	1 in 1 BLISTER PACK	02/19/2021
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	02/19/2021

Labeler - Topco Associates LLC (006935977)

Registrant - Aphena Pharma Solutions MD, LLC (829739833)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions MD, LLC		829739833	MANUFACTURE(36800-294)