Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 8f995561-759a-4837-a82a-640417a6f889

Route

NASAL

Published

Effective Date 2021-02-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2021-02-19

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 42229-5

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

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

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

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

NDC 36800-294-07

+TopCare ^®

health™

Vapor

Inhaler

LEVMETAMFETAMINE - NASAL DECONGESTANT

NET WT 0.007 OZ (198mg)

Principal Display Panel 198 Mg Blister Pack Label

NDC 36800-294-07

+TopCare ^® health™

Vapor

Inhaler

OUR PHARMACISTS

RECOMMENDED

LEVMETAMFETAMINE - NASAL DECONGESTANT

Temporary Relief of Nasal

Congestion Due to:

• Colds • Hay Fever

• Upper Respiratory Allergies

NET WT 0.007 OZ (198mg)

Structured Label Content

Use:

For temporary relief of nasal congestion due to

the common cold
hay fever or upper respiratory allergies

Section 42229-5 (42229-5)

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

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

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

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)

NDC 36800-294-07

+TopCare ^®

health™

Vapor

Inhaler

LEVMETAMFETAMINE - NASAL DECONGESTANT

NET WT 0.007 OZ (198mg)

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

NDC 36800-294-07

+TopCare ^® health™

Vapor

Inhaler

OUR PHARMACISTS

RECOMMENDED

LEVMETAMFETAMINE - NASAL DECONGESTANT

Temporary Relief of Nasal

Congestion Due to:

• Colds • Hay Fever

• Upper Respiratory Allergies

NET WT 0.007 OZ (198mg)

Advanced Ingredient Data

[{"name": "Levmetamfetamine", "unii": "Y24T9BT2Q2", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Bornyl acetate", "unii": "213431586X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Camphor (Synthetic)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Lavender oil", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Menthol", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Methyl Salicylate", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use:": "For temporary relief of nasal congestion due to the common cold hay fever or upper respiratory allergies", "42229-5": "If pregnant or breast-feeding, ask a health professional before use.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if symptoms persist", "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", "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": "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", "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": "NDC 36800-294-07 +TopCare ® health™ Vapor Inhaler LEVMETAMFETAMINE - NASAL DECONGESTANT NET WT 0.007 OZ (198mg)", "Principal Display Panel - 198 mg Blister Pack Label": "NDC 36800-294-07 +TopCare ® health™ Vapor Inhaler OUR PHARMACISTS RECOMMENDED LEVMETAMFETAMINE - NASAL DECONGESTANT Temporary Relief of Nasal Congestion Due to: • Colds • Hay Fever • Upper Respiratory Allergies NET WT 0.007 OZ (198mg)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:02.299350 · Updated: 2026-03-14T23:06:18.731306