{"clinical_pharmacology":["DIRECTIONS FOR USE Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Use Aseptic Technique. 1. Suspend container using hanger hole. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach irrigation set. Refer to complete directions accompanying set. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA ©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation. All rights reserved. 7-19-4-268 Rev. July 1997"],"effective_time":"20071101","id":"37f82301-9d3b-431a-b556-1eac1c84fff9","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Contaner Label 900 800 700 600 500 400 300 200 100 LOT EXP 1000 mL NOT FOR INJECTION 2B7634 NDC 0338-0189-4 4 Tis-U-Sol Solution (Pentalyte Irrigation) EACH 100 mL CONTAINER 800 mg SODIUM CHLORIDE USP 40 mg POTASSIUM CHLORIDE USP 20 mg MAGNESIUM SULFATE USP 8.75 mg DIBASIC SODIUM PHOSPHATE HELTAHYDRATE NF NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 6.0 (4.0 TO 7.0) OSMOLARITY 288 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Tis-U-Sol Solution (Pentalyte Irrigation) Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD, IL 60015 USA MADE IN USA PL 146 PLASTIC TIS-U-SOL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 07-25-27-636 900 800 700 600 500 400 300 200 100 Carton Label 2B7634 12-1000 ML VIAFLEX CONTAINER TIS-U-SOL SOLUTION PENTALYTE IRRIGATION EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380189446 Representative Container Label Representative Carton Label"],"set_id":"4a5ff0d7-edbb-4c54-9d09-d609d1ff3db9","spl_product_data_elements":["Tis-U-Sol Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate and potassium phosphate SODIUM CHLORIDE CHLORIDE ION SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION MAGNESIUM SULFATE MAGNESIUM CATION SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION SODIUM CATION POTASSIUM PHOSPHATE, MONOBASIC PHOSPHATE ION POTASSIUM CATION WATER"],"spl_unclassified_section":["If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."],"version":"3"}