{"active_ingredient":["Active ingredients (in each packet) Sodium Bicarbonate USP (700 mg) Sodium Chloride USP (2300 mg)"],"dosage_and_administration":["Directions Adults and children 4 years and over: Use 1/2 -1 packet per 4 fl oz (120 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."],"effective_time":"20250131","id":"2d073cca-7bcc-d1bd-e063-6294a90a0c39","inactive_ingredient":["Inactive ingredients None"],"indications_and_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"],"openfda":{"brand_name":["SinuCleanse"],"generic_name":["SODIUM BICARBONATE, SODIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["ASCENT CONSUMER PRODUCTS, INC."],"package_ndc":["42829-401-01"],"product_ndc":["42829-401"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1542919"],"spl_id":["2d073cca-7bcc-d1bd-e063-6294a90a0c39"],"spl_set_id":["c33bf872-54aa-45e0-9e40-a6565a13f198"],"substance_name":["SODIUM BICARBONATE","SODIUM CHLORIDE"],"unii":["8MDF5V39QO","451W47IQ8X"]},"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","-See enclosed instruction sheet for complete directions and proper use"],"package_label_principal_display_panel":["copy of label"],"purpose":["Purpose Nasal Wash"],"questions":["Questions? 1-888-547-5492"],"set_id":"c33bf872-54aa-45e0-9e40-a6565a13f198","spl_product_data_elements":["SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE WATER SODIUM BICARBONATE SODIUM CATION BICARBONATE ION SODIUM CHLORIDE SODIUM CATION"],"spl_unclassified_section":["Important Note: SinuCleanse Saline Packets contain 3 grams of pharmaceutical grade salt. Using the calculations in the chart, you can prepare either an Isotonic or Hypertonic Solution. Since contents of other manufacturer's Salt Packets may vary, please check with their directions for Isotonic or Hypertonic use."],"version":"7","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 Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears."]}