VAPOR INHALER  LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH - levmetamfetamine inhalant 
Topco Associates LLC

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 50mg

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

this inhaler is effective for a minimum of 3 months after first use • keep inhaler tightly closed • store at 59°-86° F (15°-30° C)

Inactive ingredients

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

Principal Display Panel - 198 mg Blister Pack Label

NDC 36800-294-07

+TopCare® health™

Vapor
Inhaler

OUR PHARMACISTS
RECOMMENDED

LEVMETAMFETAMINE - NASAL DECONGESTANT

Temporary Relief of Nasal
Congestion Due to:

• Colds • Hay Fever

• Upper Respiratory Allergies

NET WT 0.007 OZ (198mg)

Principal Display Panel - 198 mg Blister Pack Label

Principal Display Panel - 198 mg Inhaler Label

NDC 36800-294-07

+TopCare®
health™

Vapor
Inhaler

LEVMETAMFETAMINE - NASAL DECONGESTANT

NET WT 0.007 OZ (198mg)

Principal Display Panel - 198 mg Inhaler Label
VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH
levmetamfetamine inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-294
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:36800-294-071 in 1 BLISTER PACK02/19/2021
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 finalpart34102/19/2021
Labeler - Topco Associates LLC (006935977)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(36800-294)

Revised: 2/2023
Document Id: 5418bc37-f938-4835-8493-9e0492abe0cc
Set id: 8f995561-759a-4837-a82a-640417a6f889
Version: 2
Effective Time: 20230209
 
Topco Associates LLC