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| Product NDC Code | 42829-405 | ||||
|---|---|---|---|---|---|
| Drug Name | Sinucleanse squeeze |
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| Type | Brand | ||||
| Route | NASAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1542919 | ||||
| Labeler Name | ASCENT CONSUMER PRODUCTS, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 Squeeze 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 Squeeze Directions: Read through entire section before using for the first time. 1. Remove the cap from the SinuCleanse Squeeze bottle. 2. Pour the pre-mixed saline dry ingredients into the SinuCleanse Squeeze Bottle. First-time users should start with 1 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 pharmacy. 3. Fill the bottle with a proper water source * leaving approximately 1/2 inch of air at the top of the bottle. This makes 1 cup ( 8 oz. ) of solution. 4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and gently shake the bottle until the dry ingredients have completely dissolved. 5. Lean over the sink with your head bent down so you are looking directly into the basin. Place the tip of the cap up to the right nostril and gently insert the tip so that it forms a comfortable seal. Aim the tip at the back of your head, not at the top of your head. 6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort" the solution into the nose - breathe through your mouth. 7. In a few moments the solution will begin to drain out of the left nostril. Continue to squeeze the bottle gently until you have used approximately half of the solution. 8. Remove the tip of the bottle from your nostril, then exhale through both nostrils to clear them of excess mucus and solution. Gently blow your nose into a tissue. 9. Repeat the procedure on the left nostril with the remaining solution. 10. A small amount of solution will remain at the bottom of the bottle. Discard the remaining solution. 11. Thoroughly rinse the bottle after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the bottle open to air dry completely. The SinuCleanse Squeeze Bottle is also top-rack dishwasher safe. Hints for a more comfortable nasal wash - Begin using the SinuCleanse System slowly. A full pot or bottle of solution on each side is not necessary to receive the full benefit. -If the solution is too warm or too cold, the nasal wash will be uncomfortable. -If stinging or irritation occurs, try using 1/2 of a packet of dry ingredients for the Neti Pot or 1 packet per Squeeze Bottle of the saline dry ingredients. Gradually work up to using the solution at full strength. Do not use less than 1/2 packet for the Neti Pot or 1 packet per Squeeze bottle. -If you experience ear discomfort after use, try to blow your nose more gently after the wash. If the problem persists, the openings of your Eustachian tubes may be particularly wide and the use of the SinuCleanse System may need to be discontinued. -Breathe continuously through the mouth when using the SinuCleanse system to avoid solution draining from the back of the nose into the mouth. -Some people experience irritation of the skin just insdie the nostrils with repeated nasal washing. Applying a thin layer of aloe to the inside of the nostrils before or after the nasal wash will be soothing.
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 form 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