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  • TIS-U-SOL MAGNESIUM SULFATE HEPTAHYDRATE 20 mg/100mL Baxter Healthcare Corporation
FDA Drug information

TIS-U-SOL

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


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.

Indications And Usage

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

Effective Time

20140221

Version

7

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 POTASSIUM PHOSPHATE, MONOBASIC PHOSPHATE ION POTASSIUM CATION WATER

Application Number

NDA018508

Brand Name

TIS-U-SOL

Generic Name

sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate

Product Ndc

0338-0190

Product Type

HUMAN PRESCRIPTION DRUG

Route

IRRIGATION

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

How Supplied

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

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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