{"description":["DESCRIPTION Tis-U-Sol ® Solution (Pentalyte Irrigation) Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only."],"effective_time":"20140221","how_supplied":["HOW SUPPLIED Recommended storage: Room temperature (25°C). Avoid excessive heat."],"id":"313abeef-1c8f-4fb4-9e6d-3b3737102c7e","indications_and_usage":["INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection."],"openfda":{"application_number":["NDA018508"],"brand_name":["TIS-U-SOL"],"generic_name":["SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Corporation"],"package_ndc":["0338-0190-04"],"product_ndc":["0338-0190"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["IRRIGATION"],"rxcui":["801442","801445"],"spl_id":["313abeef-1c8f-4fb4-9e6d-3b3737102c7e"],"spl_set_id":["9da4121f-d62d-4da4-8dfb-0494da16015f"],"substance_name":["SODIUM CHLORIDE","POTASSIUM CHLORIDE","MAGNESIUM SULFATE HEPTAHYDRATE","SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","MONOBASIC POTASSIUM PHOSPHATE"],"unii":["451W47IQ8X","660YQ98I10","SK47B8698T","70WT22SF4B","4J9FJ0HL51"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 2F7144 NDC 0338-0190-04 1000 mL DIN 00800007 Baxter Logo Not for Injection Tis-U-Sol ® Solution (Pentalyte Irrigation) Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle. Isotonic solution for irrigation only. Dosage and Administration: As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only. Recommended storage: Room temperature (25°C). Avoid excessive heat. PL 325 plastic Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA Distributed in Canada by Baxter Corporation Mississauga, ON L5N OC2 07-09-68-118 Bar Code Position Only* 303380190041 LOT EXP Representative Container Label for Tis-U-Sol, NDC 0338-0190-04"],"set_id":"9da4121f-d62d-4da4-8dfb-0494da16015f","spl_product_data_elements":["TIS-U-SOL sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate SODIUM CHLORIDE SODIUM CATION CHLORIDE ION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION MAGNESIUM SULFATE HEPTAHYDRATE MAGNESIUM CATION SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM CATION PHOSPHATE ION MONOBASIC POTASSIUM PHOSPHATE PHOSPHATE ION POTASSIUM CATION WATER"],"version":"10"}