9da4121f-d62d-4da4-8dfb-0494da16015f

Drug Facts

Composition & Product

Active Ingredients

chloride ion (800 mg) magnesium cation (40 mg) phosphate ion (20 mg) potassium cation (8.75 mg)

Inactive Ingredients

water

Identifiers & Packaging

Marketing Status

nda active Since 1982-02-19

Medication Information

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.

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.

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

Structured Label Content

Indications and Usage (INDICATIONS AND USAGE)

Isotonic solution for irrigation only. Not for injection.

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.

How Supplied (HOW SUPPLIED)

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

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.

Principal Display Panel Packaging Labeling (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

Advanced Ingredient Data

[{"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "800", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "8.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM CATION", "unii": "295O53K152", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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

9da4121f-d62d-4da4-8dfb-0494da16015f

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information