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| Product NDC Code | 70000-0270 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Leader sinus wash saline refill packets |
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| Type | Brand | ||||||
| Pharm Class | Alkalinizing Activity [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||||
| Dosage Form | POWDER, FOR SOLUTION | ||||||
| RxCUI drug identifier | 1542919 | ||||||
| Labeler Name | Cardinal Health, 110 dba LEADER | ||||||
| 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 sheetfor complete directions and proper use
| Children under 4 years: | Consult a physician |
| See enclosed instruction sheetfor 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 •Runny nose •Nasal stuffiness •Post nasal drip •Removes inhaled irritants (dust, pollen) •Promotes 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.Leader Sinus Wash Saline Refill Packets SODIUM BICARBONATE, SODIUM CHLORIDE WATER SODIUM BICARBONATE BICARBONATE ION SODIUM CHLORIDE SODIUM CATION
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.image description
image description
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 # and expiration date
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-547-5492
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.image description
image description
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 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