Label: REFILL SALINE PACKETS- sodium bicarbonate, sodium chloride powder, for solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 31, 2013

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  • PURPOSE

    Purpose

    Nasal Wash

  • INDICATIONS & USAGE

     Uses

    Temporarily relieves symptoms associated with sinusitis, cold, flu or allergies

    -Sneezing

    -Nasal Stuffiness

    -Runny Nose

    -Post nasal drip

    Removes inhaled irritants (dust, pollen)

    Helps to loosen thick mucous

    Moistens nasal passages

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach from children

  • WARNINGS

    Warnings

    Stop use and ask a doctor if washing is uncomfortable or symptoms are not relieved or worsen

    after nasal rinsing, especially if fever, nosebleeds or headache are present


  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: use 1-2 packets every 8 oz every 2 hours as needed

    Children under 4 years: consult a physician

    Consult Instructions for Use for proper use



  • OTHER SAFETY INFORMATION

    Other Information

    -Inspect saline solution packets for integrity

    -Do not use if open or torn

    -Protect saline solution packets form excessive heat and moisture


  • INSTRUCTIONS FOR USE

     Instructions for Use:

    Directions: Read through entire section before using for the first time

    1. Empty the contents of one Instant Relief Sinus Wash packet into the Sinus Wash Neti Pot. First-time users should start with a 1/2 packet of the dry ingredients. As you become more accustomed to the

    system, work up to using 1 full packet. Additional packets may be purchased form your nearest pharmacy.

    2. Fill the pot halfway or to the middle of the indentation with proper water. This makes 1/2 cup (4 oz) solution.

    3. Stir thoroughly until dry ingredients have completely dissolved.

    4. Proper head position allows solution to run through the nose by gravity.

    -Lean over the sink with your head bent down so you are looking directly into the basin. Holding the pot in your right hand, gently insert the spout into your right nostril so that it forms a comfortable seal.

    -Rotate your head so that the right nostril is directly over the left. The forehead should remain higher than the chin. Raise the handle of the pot so that the solution enters the right nostril. IN a few moments,

    the solution will begin to drain out of the left nostril into the sink.  Do not inhale or "snort" solution into the nose - breathe through your mouth.

    5. When the pot is empty, exhale through both nostrils to clear them of excess mucous and solution. Gently blow your nose into a tissue.

    6. Repeat the procedure on the other side.

    7. Thoroughly rinse the pot after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry completely. The Instant Relief Sinus Wash Neti Pot is

    top-rack dishwasher safe.

  • ACTIVE INGREDIENT

    Active Ingredients

    (in each packet)

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 2300 mg

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    REFILL SALINE PACKETS 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-408
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2300 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE700 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-408-00100 in 1 CARTON
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - CVS Pharmacy (062312574)