SINU INHALER- levmetamfetamine nasal decongestant inhalant

Sinu Inhaler by

Drug Labeling and Warnings

Sinu Inhaler by is a Otc medication manufactured, distributed, or labeled by NeilMed, Aphena Pharma Solutions-New York, LLC, Aphena Pharma Solutions-Maryland, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use for temporary relief of nasal congestion due to:

• the common cold
• hay fever or upper respiratory allergies

Warnings

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.

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 (15o- 30oC)

Inactive Ingredients:

bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

Questions or comments? 1-707-525-3784

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

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

INGREDIENTS AND APPEARANCE

SINU INHALER 
levmetamfetamine nasal decongestant inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-281
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2)	LEVMETAMFETAMINE	50 mg

Inactive Ingredients
Ingredient Name	Strength
BORNYL ACETATE (UNII: 213431586X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-281-07	1 in 1 BLISTER PACK	06/15/2014
1		198 in 1 INHALER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/15/2014

Labeler - NeilMed (783557783)

Registrant - Aphena Pharma Solutions-New York, LLC (078573647)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions-Maryland, LLC		829739833	manufacture(13709-281) , pack(13709-281) , label(13709-281)