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

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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 DrugM01202/19/2021
Labeler - Topco Associates LLC (006935977)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(36800-294)

Revised: 12/2024
Document Id: 5ff33a27-60d6-4de1-be38-9b45f1f56209
Set id: 8f995561-759a-4837-a82a-640417a6f889
Version: 3
Effective Time: 20241220
 
Topco Associates LLC