Sinu Inhaler
FDA Label NDC 13709-281

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals, Inc. for the product Sinu Inhaler (NDC 13709-281). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per inhaler), purpose, use for temporary relief of nasal congestion due to:, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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