VAPOR INHALER- levmetamfetamine nasal decongestant inhalant 
Cardinal Health (Leader)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use for temporary relief of nasal congestion due to:

Warnings

When using this product

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

adults and children 12 years of age and over2 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 ageask a doctor
children under 2 years of agedo not use

Other Information

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)

image description

VAPOR INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-045
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2) LEVMETAMFETAMINE50 mg
Inactive Ingredients
Ingredient NameStrength
BORNYL ACETATE (UNII: 213431586X)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-045-981 in 1 BLISTER PACK
1198 in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2014
Labeler - Cardinal Health (Leader) (097537435)
Registrant - Aphena Pharma Solutions-New York, LLC (078573647)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions-New York, LLC078573647manufacture(49781-045) , pack(49781-045) , label(49781-045)

Revised: 3/2014
Document Id: ad0edecb-408c-4f30-b290-41c886883488
Set id: 7a0a343c-efa5-4e66-80e0-2e6b56b86ff4
Version: 1
Effective Time: 20140316
 
Cardinal Health (Leader)