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Vapor Inhaler by Chain Drug Marketing Association, Inc.

Medically reviewed on March 26, 2018

Dosage form: inhalant
Ingredients: LEVMETAMFETAMINE 50mg
Labeler: Chain Drug Marketing Association, Inc.
NDC Code: 63868-267

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 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? 248-449-9300

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile Novi, MI 48376

Questions: 248-449-9300

Made in the USA    BCQC01.   Rev. 06/13

PRINCIPAL DISPLAY PANEL - Vapor Inhaler

QC®

Quality Choice

NDC 63868-267-01

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine | Nasal Decongestant

Temporary Relief of

Nasal Congestion due to:

Colds | Hay Fever

Upper Respiratory Allergies

*Compare to the active ingredient in Vicks®

Vapoinhaler

NET WT .007 oz (198 mg)

VAPOR INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-267
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:63868-267-011 INHALER in 1 BLISTER PACK
1198 INHALANT in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Registrant - Aphena Pharma Solutions - New York LLC (078573647)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions - New York , LLC078573647manufacture(63868-267), pack(63868-267), label(63868-267)

 
Chain Drug Marketing Association, Inc.

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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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