Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 44f72f34-d0b8-421f-b240-86286de874cf
Route
NASAL
Published
Effective Date 2021-02-24
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 2021-02-24
Description

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Levmetamfetamine 50 mg

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 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
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?

1-877-932-7948

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
Active Ingredient (per Inhaler)

Levmetamfetamine 50 mg

Principal Display Panel 198 Mg Blister Pack Label

NDC 41163-031-01

compare to Original

Vicks ® Vapolnhaler ®

active ingredient*

EQUALINE ®

nasal decongestant

vapor inhaler

levmetamfetamine

(nasal decongestant)

temporary relief of

nasal congestion due to:

  • colds • hay fever
  • upper respiratory allergies

NET WT .007 OZ (198mg)

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 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
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?)

1-877-932-7948

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
  • do not use for more than 7 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Active Ingredient (per Inhaler) (Active ingredient (per inhaler))

Levmetamfetamine 50 mg

Principal Display Panel 198 Mg Blister Pack Label (Principal Display Panel - 198 mg Blister Pack Label)

NDC 41163-031-01

compare to Original

Vicks ® Vapolnhaler ®

active ingredient*

EQUALINE ®

nasal decongestant

vapor inhaler

levmetamfetamine

(nasal decongestant)

temporary relief of

nasal congestion due to:

  • colds • hay fever
  • upper respiratory allergies

NET WT .007 OZ (198mg)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:21.053355 · Updated: 2026-03-14T23:07:01.452935