WELL AT WALGREENS (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [WALGREEN COMPANY]

WELL AT WALGREENS (SODIUM BICARBONATE, SODIUM CHLORIDE) POWDER, FOR SOLUTION [WALGREEN COMPANY]
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NDC 0363-0801-00, 0363-0801-10
Set ID cb5d3d9d-2481-4303-b6af-0002de8c9065
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number
  • 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)

    Removes nasal and sinus drainage

    Helps reduce swelling of nasal membranes

    Moisturizes dry nasal passages

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • WARNINGS

    Warnings

    Stop use and ask a doctor if washing is uncomfortable

    or symptoms are not relieved.

    Do not use unfiltered tap water. see instructions inside box for proper water sources


  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: Use 1-2 packets  per 8 fl oz (240 mL) up to every 2 hours as needed.



    Children under 4 years: Consult a physician

    See enclosed instruction sheet for complete directions and proper use.

  • INSTRUCTIONS FOR USE

    Instructions for use

    USES:

    Temporarily relieves symptoms associated with sinusitis, colds, flu or allergies, including nasal stuffiness, sneezing, runny nose and post-nasal

    drip. Removes inhaled irritants (e.g. dust, pollen, smoke). Promotes nasal and sinus drainage. Helps reduce swelling of nasal membranes.

    DOSAGE:

    Adults and children age 4 years and older may use 1-2 packets of dry ingredients administered as described below as often as

    every 2 hours. For children under age 4 consult a health care professional before use.

    DIRECTIONS: 

    Read through entire section before using for the first time.

    1. Remove the cap from the Walgreens Kettle Neti Pot.

    2. Pour the pre-mixed saline dry into the Walgreens Kettle Neti Pot. First-time users

    should start with one packet of the saline dry ingredients.As you become more accustomed to the system, work up to using 2 full packets.

    Additional packets may be purchased from your nearest Walgreens pharmacy.

    3. Fill the pot to the 8 oz line with distilled, sterile, or filtered water (using a filter with an absolute pore size of 1 micron or smaller)

    or previously boiled (boil water 1 minute or 3 minutes if at elevations above 6,500 feet then allow to cool to body temperature) water.

    This makes 1/2 cup (4 oz) of solution.

    4. Tighten the cap on the pot securely,  place one finger over the spout and one over the hole on the cap and gently shake the pot until

    the dry ingredients have completely dissolved..

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

    -Lean over the sink 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 above 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.

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

    7. 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 ;eave the pot to air dry completely.

    The Walgreens Kettle 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

  • OTHER SAFETY INFORMATION

    Other Information

    -Inspect saline packets for integrity

    -Do not use saline packets if open or torn

    -Protect saline packets from excessive heat and moisture

    -See saline packets or box for lot # and expiration date

  • QUESTIONS

    Questions?

    1-888-547-5492

  • OTHER SAFETY INFORMATION

    -See instruction sheet for use


  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    WELL AT WALGREENS  
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0801
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0801-10100 in 1 BOX04/01/2013
    1NDC:0363-0801-003000 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Labs, Inc.117337220manufacture(0363-0801)

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