VAPOR INHALER  LEVMETAMFETAMINE NASAL DECONGESTANT, DG HEALTH - levmetamfetamine inhalant 
Dolgencorp 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.

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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

Inactive ingredients

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

Questions or comments?

1-888-309-9030

Principal Display Panel - 198 mg Blister Pack Label

DG™|health

Temporarily
Relieves Stuffy
Nose

NDC 55910-265-24

Vapor Inhaler

Levmetamfetamine...Nasal Decongestant

TEMPORARY RELIEF FROM
NASAL CONGESTION

COLDS | HAY FEVER

UPPER RESPIRATORY ALLERGIES

SEE DRUG FACTS

TAMPER EVIDENT:
Use only if perforated
tube label is intact.

NET WT 0.007 OZ

(198 mg)

Principal Display Panel - 198 mg Blister Pack Label

Principal Display Panel - 198 mg Inhaler Label

DG™|health

NDC 55910-265-24

Vapor Inhaler

Levmetamfetamine...Nasal Decongestant

NET WT 0.007 OZ (198 mg)

Principal Display Panel - 198 mg Inhaler Label
VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, DG HEALTH
levmetamfetamine inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-265
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:55910-265-241 in 1 BLISTER PACK02/23/2021
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 finalpart34102/23/2021
Labeler - Dolgencorp Inc. (068331990)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(55910-265)

Revised: 2/2023
Document Id: cebd2a86-9932-4cc5-8ddc-255fd3a20382
Set id: 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3
Version: 2
Effective Time: 20230210
 
Dolgencorp Inc.