Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 3ec7309d-96e9-44f3-bb98-dbfba0c29c0a

Route

NASAL

Published

Effective Date 2014-06-15

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 FINAL Active Since 2014-06-15

Description

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Levmetamfetamine 50 mg

Section 42229-5

TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT

DISTRIBUTED BY NeilMed® Pharmaceuticals, Inc.

601 Aviation Blvd., Santa Rosa, CA 95403 USA

www.NeilMed.com Made in the USA BCNM01 Rev. 04/14

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? 1 707 525 3784

Principal Display Panel Sinu Inhaler

NEW

NDC 13709-281-07

NeilMed®

Sinu Inhaler™

Nasal Decongestant

_______________________

Levmetamfetamine - Nasal Decongestant

Temporary

Relief of Nasal Congestion due to:

Upper Respiratory Allergies

Cold • Hay Fever

Net Wt 0.007 OZ (198 mg) See Drug Facts

6031-ENU-US-rev1-PP20140409zm

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 BY NeilMed® Pharmaceuticals, Inc.

601 Aviation Blvd., Santa Rosa, CA 95403 USA

www.NeilMed.com Made in the USA BCNM01 Rev. 04/14

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? 1 707 525 3784 (Questions or comments? 1-707-525-3784)

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

NEW

NDC 13709-281-07

NeilMed®

Sinu Inhaler™

Nasal Decongestant

_______________________

Levmetamfetamine - Nasal Decongestant

Temporary

Relief of Nasal Congestion due to:

Upper Respiratory Allergies

Cold • Hay Fever

Net Wt 0.007 OZ (198 mg) See Drug Facts

6031-ENU-US-rev1-PP20140409zm

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 BY NeilMed® Pharmaceuticals, Inc. 601 Aviation Blvd., Santa Rosa, CA 95403 USA www.NeilMed.com Made in the USA BCNM01 Rev. 04/14", "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 - Sinu Inhaler": " NEW NDC 13709-281-07 NeilMed® Sinu Inhaler™ Nasal Decongestant _______________________ Levmetamfetamine - Nasal Decongestant Temporary Relief of Nasal Congestion due to: Upper Respiratory Allergies Cold • Hay Fever Net Wt 0.007 OZ (198 mg) See Drug Facts 6031-ENU-US-rev1-PP20140409zm", "Use for temporary relief of nasal congestion due to:": "the common cold hay fever or upper respiratory allergies"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:28.152732 · Updated: 2026-03-14T22:59:26.836242