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 FINAL Active Since 2016-07-01

Medication Information

Purpose

Nasal decongestant

Description

Levmetamfetamine 50 mg

Section 42229-5

TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

Distributed & Manufactured by: Aphena Pharma Solutions

7978 Industrial Park Road, Easton, MD 21601 USA

www.aphenapharma.com

Made in the USA BCAPS01 Rev. 01/17, LAAPS01 Rev. 01/17

Warnings

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^o-86^oF (15^o- 30^oC)

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
do not use for more than 7 days
Use only as directed
frequent or prolonged use may cause nasal congestion to recur or worsen

Stop Use and Ask A Doctor If

symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (per Inhaler)

Levmetamfetamine 50 mg

Questions Or Comments? 1 877 586 7979

Principal Display Panel Vapor Inhaler

_______________________

NDC 54884-050-01

Aphena Pharma Solutions

Nasal Decongestant Inhaler

Levmetamfetamine

_______________________

Levmetamfetamine 50mg - Nasal Decongestant

Use for temporary relief of nasal decongestion

due to:

• the common cold

• hay fever or upper respiratory allergies

Net Wt 0.007 OZ (198 mg) Per Inhaler See Drug Facts

Use for Temporary Relief of Nasal Congestion Due To:

the common cold
hay fever or upper respiratory allergies

Structured Label Content

Section 42229-5 (42229-5)

TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

Distributed & Manufactured by: Aphena Pharma Solutions

7978 Industrial Park Road, Easton, MD 21601 USA

www.aphenapharma.com

Made in the USA BCAPS01 Rev. 01/17, LAAPS01 Rev. 01/17

Purpose

Nasal decongestant

Warnings

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^o-86^oF (15^o- 30^oC)

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
do not use for more than 7 days
Use only as directed
frequent or prolonged use may cause nasal congestion to recur or worsen

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

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

Levmetamfetamine 50 mg

Questions Or Comments? 1 877 586 7979 (Questions or comments? 1-877-586-7979)

Principal Display Panel Vapor Inhaler (PRINCIPAL DISPLAY PANEL - Vapor Inhaler)

_______________________

NDC 54884-050-01

Aphena Pharma Solutions

Nasal Decongestant Inhaler

Levmetamfetamine

_______________________

Levmetamfetamine 50mg - Nasal Decongestant

Use for temporary relief of nasal decongestion

due to:

• the common cold

• hay fever or upper respiratory allergies

Net Wt 0.007 OZ (198 mg) Per Inhaler See Drug Facts

Use for Temporary Relief of Nasal Congestion Due To: (Use for temporary relief of nasal congestion due to:)

the common cold
hay fever or upper respiratory allergies

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)

{"42229-5": "TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT Distributed & Manufactured by: Aphena Pharma Solutions 7978 Industrial Park Road, Easton, MD 21601 USA www.aphenapharma.com Made in the USA BCAPS01 Rev. 01/17, LAAPS01 Rev. 01/17", "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": "this inhaler is effective for a minimum of 3 months after first use keep inhaler tightly closed store at 59 o -86 o F (15 o - 30 o 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 do not use for more than 7 days Use only as directed frequent or prolonged use may cause nasal congestion to recur or worsen", "Stop use and ask a doctor if": "symptoms persist", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Active ingredient (per inhaler)": "Levmetamfetamine 50 mg", "PRINCIPAL DISPLAY PANEL - Vapor Inhaler": " _______________________ NDC 54884-050-01 Aphena Pharma Solutions Nasal Decongestant Inhaler Levmetamfetamine _______________________ Levmetamfetamine 50mg - Nasal Decongestant Use for temporary relief of nasal decongestion due to: • the common cold • hay fever or upper respiratory allergies Net Wt 0.007 OZ (198 mg) Per Inhaler See Drug Facts", "Use for temporary relief of nasal congestion due to:": "the common cold hay fever or upper respiratory allergies"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information