SINU INHALER- levmetamfetamine nasal decongestant inhalant 
NeilMed Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (per inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use for temporary relief of nasal congestion due to:

Warnings

When using this product

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

adults and children 12 years of age and over2 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 ageask a doctor
children under 2 years of agedo not use

Other Information

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

image description

SINU INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-281
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Levmetamfetamine (UNII: Y24T9BT2Q2) (Levmetamfetamine - UNII:Y24T9BT2Q2) Levmetamfetamine50 mg
Inactive Ingredients
Ingredient NameStrength
Bornyl acetate (UNII: 213431586X)  
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Lavender oil (UNII: ZBP1YXW0H8)  
Menthol (UNII: L7T10EIP3A)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-281-071 in 1 BLISTER PACK06/15/2014
1198 in 1 INHALER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2014
Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(13709-281)

Revised: 12/2018
Document Id: 3791224b-7c5a-47e8-8054-75c3d620bc0e
Set id: 3ec7309d-96e9-44f3-bb98-dbfba0c29c0a
Version: 3
Effective Time: 20181218
 
NeilMed Pharmaceuticals, Inc.