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Sinucleanse - Medication Information

Product NDC Code 42829-408
Drug Name

Sinucleanse

Type Brand
Pharm Class Increased Large Intestinal Motility [PE],
Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Osmotic Activity [MoA],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Osmotic Laxative [EPC]
Active Ingredients
Sodium bicarbonate 22.2 mg/100mg
Sodium chloride 77.8 mg/100mg
Route NASAL
Dosage Form POWDER, FOR SOLUTION
RxCUI drug identifier 1542919
Labeler Name ASCENT CONSUMER PRODUCTS, INC.
Packages
Package NDC Code Description
42829-408-00 100 packet in 1 carton (42829-408-00) / 3000 mg in 1 packet
42829-408-60 60 packet in 1 carton (42829-408-60) / 3000 mg in 1 packet
Check if available Online

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 - 1 packet per 4 fl oz (120 mL)up to every two 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 -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.
SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE WATER SODIUM BICARBONATE SODIUM CATION 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.
label copy of label

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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product: -Use by only one person -Wash with soap and water after each use -Top rack of dishwasher safe -Do not heat in microwave

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