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Vapor Inhaler by Cardinal Health (Leader)

Medically reviewed on March 16, 2018

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

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.

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 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
  • ​this inhaler is effective for a minimum of 3 months after first use
  • keep inhaler tightly closed
  • store at 59​o-86​o​F (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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-045
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVMETAMFETAMINE (LEVMETAMFETAMINE) LEVMETAMFETAMINE50 mg
Inactive Ingredients
Ingredient NameStrength
BORNYL ACETATE 
CAMPHOR (SYNTHETIC) 
LAVENDER OIL 
MENTHOL 
METHYL SALICYLATE 
Packaging
#Item CodePackage Description
1NDC:49781-045-981 INHALER in 1 BLISTER PACK
1198 INHALANT 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/FEIOperations
Aphena Pharma Solutions-New York, LLC078573647manufacture(49781-045), pack(49781-045), label(49781-045)

 
Cardinal Health (Leader)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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