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Sinu Inhaler

Medically reviewed by Drugs.com. Last updated on Dec 8, 2020.

Dosage form: inhalant
Ingredients: LEVMETAMFETAMINE 50mg
Labeler: NeilMed
NDC Code: 13709-281

Drug Facts

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 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
  • ​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

SINU INHALER 
levmetamfetamine nasal decongestant inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-281
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVMETAMFETAMINE (LEVMETAMFETAMINE) LEVMETAMFETAMINE50 mg
Inactive Ingredients
Ingredient NameStrength
BORNYL ACETATE 
CAMPHOR (SYNTHETIC) 
LAVENDER OIL 
MENTHOL, UNSPECIFIED FORM 
METHYL SALICYLATE 
Packaging
#Item CodePackage Description
1NDC:13709-281-071 INHALER in 1 BLISTER PACK
1198 INHALANT in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2014
Labeler - NeilMed (783557783)
Registrant - Aphena Pharma Solutions-New York, LLC (078573647)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions-Maryland, LLC829739833manufacture(13709-281), pack(13709-281), label(13709-281)

Document Id: 7a55e496-ac10-4a0c-ab5e-2e21d64ed5bc
Set id: 3ec7309d-96e9-44f3-bb98-dbfba0c29c0a
Version: 2
Effective Time: 20181218
 
NeilMed

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer