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  5. Label Information: Sinu Inhaler

FDA Label for Sinu Inhaler

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (PER INHALER)
    2. PURPOSE
    3. USE FOR TEMPORARY RELIEF OF NASAL CONGESTION DUE TO:
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS:
    12. QUESTIONS OR COMMENTS? 1-707-525-3784
    13. PRINCIPAL DISPLAY PANEL - SINU INHALER

Sinu Inhaler Product Label

The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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