Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 77924474-ccc7-497b-9168-91490bcfadfc
Route
NASAL
Published
Effective Date 2023-03-06
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 2016-07-01

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 50567-7

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
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?

1-800-walgreens (1-800-925-4733)

Active Ingredient (per Inhaler)

Levmetamfetamine 50 mg

Principal Display Panel – 3 Inhaler Carton

VALUE SIZE

NDC 0363-0564-53

Contains 3 of NDC 0363-0564-50

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Vapor Inhaler

LEVMETAMFETAMINE / NASAL DECONGESTANT

Nasal Decongestant

NET WT 0.007 OZ (198 mg) PER INHALER

TOTAL NET WT 0.021 0Z (594 mg)

3

INHALERS


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 50567-7 (50567-7)

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
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?)

1-800-walgreens (1-800-925-4733)

Active Ingredient (per Inhaler) (Active ingredient (per inhaler))

Levmetamfetamine 50 mg

Principal Display Panel – 3 Inhaler Carton

VALUE SIZE

NDC 0363-0564-53

Contains 3 of NDC 0363-0564-50

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Vapor Inhaler

LEVMETAMFETAMINE / NASAL DECONGESTANT

Nasal Decongestant

NET WT 0.007 OZ (198 mg) PER INHALER

TOTAL NET WT 0.021 0Z (594 mg)

3

INHALERS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)