VAPOR INHALER- levmetamfetamine nasal decongestant inhalant 
C.D.M.A., Inc.

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:

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

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

Inactive ingredients

bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

Questions or comments?

800-935-2362

Principal Display Panel – 198 mg Blister Pack Label

NDC 63868-267-01

QC®

QUALITY
CHOICE

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine
Temporary Relief of
Nasal Congestion Due to
Colds,
Hay Fever
Upper Respiratory Allergies

NET WT 0.007 OZ (198 mg)

Principal Display Panel – 198 mg Blister Pack Label
VAPOR INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-267
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:63868-267-011 in 1 BLISTER PACK01/01/2014
1198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - C.D.M.A., Inc. (011920774)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(63868-267)

Revised: 2/2023
Document Id: ac200f17-cfbd-4bd6-a2cc-a64d8040887c
Set id: 904b7e21-cce5-4b96-afc1-b36f532f98ac
Version: 4
Effective Time: 20230213
 
C.D.M.A., Inc.