Vapor Inhaler

Dosage form: inhalant
Ingredients: LEVMETAMFETAMINE 50mg
Labeler: Cardinal Health (Leader)
NDC code: 49781-045

Medically reviewed by Drugs.com. Last updated on Mar 6, 2024.

Drug Facts

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 59o-86oF (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

*This product is not manufactured or distributed by Procter & Gamble, distributor

of Vicks® VapoInhaler®. Vicks® VapoInhaler® is a trademark of Procter & Gamble.

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313 CIN 4914057

Made in the USA BCLE01 Rev. 06/13

PRINCIPAL DISPLAY PANEL - Vapor Inhaler

Leader

NDC 49781-045-98

Compare to Vicks® VapoInhaler®

active ingredient*

Nasal Decongestant

Vapor Inhaler

Levmetamfetamine • Nasal Decongestant

Temporary Relief of Nasal Congestion due to:

•Colds • Hay Fever

•Upper Respiratory Allergies

Satisfaction Guaranteed

NET WT .007 oz (198 mg)

VAPOR INHALER
levmetamfetamine nasal decongestant inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49781-045
Route of Administration	NASAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVMETAMFETAMINE (LEVMETAMFETAMINE)	LEVMETAMFETAMINE	50 mg

Inactive Ingredients
Ingredient Name	Strength
BORNYL ACETATE
CAMPHOR (SYNTHETIC)
LAVENDER OIL
MENTHOL
METHYL SALICYLATE

Packaging
#	Item Code	Package Description
1	NDC:49781-045-98	1 INHALER in 1 BLISTER PACK
1		198 INHALANT in 1 INHALER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2014

Labeler - Cardinal Health (Leader) (097537435)

Registrant - Aphena Pharma Solutions-New York, LLC (078573647)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions-New York, LLC		078573647	manufacture(49781-045), pack(49781-045), label(49781-045)

Document Id: ad0edecb-408c-4f30-b290-41c886883488

Set id: 7a0a343c-efa5-4e66-80e0-2e6b56b86ff4

Version: 1

Effective Time: 20140316

Cardinal Health (Leader)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer