DailyMed - TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

NDC Code(s): 0338-0190-04
Packager: Baxter Healthcare Corporation

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated February 21, 2014

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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.
INDICATIONS AND USAGE

Isotonic solution for irrigation only. Not for injection.
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.
HOW SUPPLIED

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

INGREDIENTS AND APPEARANCE

TIS-U-SOL
sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0338-0190
Route of Administration	IRRIGATION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	800 mg in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	40 mg in 100 mL
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	20 mg in 100 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	8.75 mg in 100 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152)	POTASSIUM PHOSPHATE, MONOBASIC	6.25 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0338-0190-04	12 in 1 CARTON	02/19/1982
1		1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018508	02/19/1982

Labeler - Baxter Healthcare Corporation (005083209)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Healthcare Corporation		001728059	ANALYSIS(0338-0190) , MANUFACTURE(0338-0190) , LABEL(0338-0190) , PACK(0338-0190) , STERILIZE(0338-0190)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Healthcare Corporation		194684502	ANALYSIS(0338-0190)

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Published Date (What is this?)	Version	Files
Sep 4, 2023	7 (current)	download
Dec 30, 2022	6	download
Jul 21, 2021	5	download
Nov 2, 2020	4	download
Jan 10, 2019	3	download
Jun 2, 2014	2	download
Jun 18, 2012	1	download

Published Date (What is this?)

Version

Files

Sep 4, 2023

7 (current)

download

Dec 30, 2022

download

Jul 21, 2021

download

Nov 2, 2020

download

Jan 10, 2019

download

Jun 2, 2014

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Jun 18, 2012

download

	RxCUI	RxNorm NAME	RxTTY
1	801442	magnesium sulfate 0.2 MG/mL / monobasic K+ phosphate 0.063 MG/mL / K+ chloride 0.005 MEQ/mL / NaCl 0.14 MEQ/mL / sodium phosphate dihydrate 0.088 MG/mL Irrigation Solution	PSN
2	801442	magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution	SCD
3	801442	Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution	SY
4	801442	Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution	SY
5	801445	Tis-U-Sol 20 MG / 6.25 MG / 40 MG / 800 MG / 8.75 MG per 100 ML Irrigation Solution	PSN
6	801445	magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution [Tis-U-Sol]	SBD
7	801445	Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]	SY
8	801445	Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]	SY
9	801445	Tis-U-Sol Irrigation Solution	SY
10	801445	Tis-U-Sol (magnesium sulfate 20 MG / monobasic potassium phosphate 6.25 MG / potassium chloride 40 MG / sodium chloride 800 MG / sodium phosphate dihydrate 8.75 MG per 100 ML) Irrigation Solution	SY

RxCUI

RxNorm NAME

RxTTY

801442

magnesium sulfate 0.2 MG/mL / monobasic K+ phosphate 0.063 MG/mL / K+ chloride 0.005 MEQ/mL / NaCl 0.14 MEQ/mL / sodium phosphate dihydrate 0.088 MG/mL Irrigation Solution

PSN

801442

magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution

SCD

801442

Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution

801442

Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution

801445

Tis-U-Sol 20 MG / 6.25 MG / 40 MG / 800 MG / 8.75 MG per 100 ML Irrigation Solution

PSN

801445

magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution [Tis-U-Sol]

SBD

801445

Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]

801445

Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]

801445

Tis-U-Sol Irrigation Solution

801445

Tis-U-Sol (magnesium sulfate 20 MG / monobasic potassium phosphate 6.25 MG / potassium chloride 40 MG / sodium chloride 800 MG / sodium phosphate dihydrate 8.75 MG per 100 ML) Irrigation Solution

Label: TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

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Label: TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

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TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

Number of versions: 7

TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

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TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

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