DESCRIPTION SECTION.

DESCRIPTION. Tis-U-Sol(R) 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 & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. As directed by physician.Cautions: Warm in oven to not more than 50C for 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Recommended storage: Room temperature (25C). Avoid excessive heat.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Isotonic solution for irrigation only. Not for injection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL PACKAGING LABELING. 2F7144NDC 0338-0190-041000 mLDIN 00800007Baxter LogoNot for InjectionTis-U-Sol(R) 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 physician. Cautions: Warm in oven to not more than 50C for 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 (25C). Avoid excessive heat. PL 325 plasticBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in USADistributed in Canada byBaxter CorporationMississauga, ONL5N OC207-09-68-118Bar Code Position Only303380190041LOTEXPCarton LabelCarton LabelTIS-U-SOL(R) Solution(Pentalyte Irrigation)Pour Bottle1000 mLQty12NDC 0338-0190-042F7144EXPLOT Bar Code(01)50303380190046(17)080630(10)G012345. Representative Container Label for Tis-U-Sol, NDC 0338-0190-04. TIS-U-SOL Solution Representative Carton Label.