Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3
Route
NASAL
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levmetamfetamine (50 mg)
Inactive Ingredients
Bornyl Acetate Camphor (synthetic) Lavender Oil Menthol Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-23
Description

per inhaler: Levmetamfetamine 50mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

per inhaler: Levmetamfetamine 50mg

Use:

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50570-1
  • do not use for more than 7 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 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
Active Ingredient

per inhaler:

Levmetamfetamine 50mg

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

Questions Or Comments?

1-888-309-9030

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
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 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)

Structured Label Content

Use:

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50570-1 (50570-1)
  • do not use for more than 7 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

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 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
Active Ingredient (Active ingredient)

per inhaler:

Levmetamfetamine 50mg

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-309-9030

When Using This Product (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
Principal Display Panel 198 Mg Inhaler 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 Blister Pack Label (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:02.229555 · Updated: 2026-03-14T23:06:18.731306