Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 904b7e21-cce5-4b96-afc1-b36f532f98ac
Route
NASAL
Published
Effective Date 2023-02-13
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 2014-01-01
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 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
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?

800-935-2362

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
Active Ingredient (per Inhaler)

Levmetamfetamine 50 mg

Principal Display Panel – 198 Mg Blister Pack Label

NDC 63868-267-01

QC ®

QUALITY

CHOICE

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine

Temporary Relief of

Nasal Congestion Due to

Colds,

Hay Fever

Upper Respiratory Allergies

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
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?)

800-935-2362

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
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 63868-267-01

QC ®

QUALITY

CHOICE

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine

Temporary Relief of

Nasal Congestion Due to

Colds,

Hay Fever

Upper Respiratory Allergies

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: 2026-02-15T12:05:02.301673 · Updated: 2026-03-14T23:06:18.731306