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Sinucleanse neti-pot - Medication Information

Product NDC Code 42829-402
Drug Name

Sinucleanse neti-pot

Type Brand
Route NASAL
Dosage Form KIT
RxCUI drug identifier 1542919
Labeler Name ASCENT CONSUMER PRODUCTS, INC.
Packages
Package NDC Code Description
42829-402-30 1 kit in 1 kit (42829-402-30) * 3000 mg in 1 packet (42829-401-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each packet) Sodium Bicarbonate USP (700 mg) Sodium Chloride USP (2300 mg)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients None

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Nasal Wash

Spl product data elements

Usually a list of ingredients in a drug product.
SinuCleanse Neti-Pot SODIUM BICARBONATE, SODIUM CHLORIDE SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE WATER SODIUM CHLORIDE SODIUM CATION SODIUM BICARBONATE SODIUM CATION BICARBONATE ION

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
copy of label

Instructions for use

Information about safe handling and use of the drug product.
Instructions for Use of the SinuCleanse Neti Pot Directions: Read through entire section before using for the first time. 1. Empty the contents of one SinuCleanse Saline Wash packet into the SinuCleanse Neti Pot. First-time users should start with 1/2 packet of the SinuCleanse dry ingredients. As you become more accustomed to the system, work up to using 1 full packet. Additional packets may be purchased from your nearest pharmacy. 2. Fill the pot halfway or to the middle of the indentation with a proper water source.* This makes 1/2 cup (4 oz. ) solution. 3. Stir thoroughly until dry ingredients have completely dissolved. 4. Proper head position allows solution to flow 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 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 begn to drain out the left nostril into the sink. Do not inhale or "snort" solution into the nose - breathe through your mouth. 5. When the pot i empty, exhale through both nostrils to clear them of excess mucus 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 SinuCleanse Neti Pot is top-rack dishwasher safe.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
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 number and expiration date Questions? 1-888-547-5492

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API