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

TIS-U-SOL by

Drug Labeling and Warnings

TIS-U-SOL by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Carton Label

Carton Label

TIS-U-SOL® Solution
(Pentalyte Irrigation)
Pour Bottle

1000 mL

Qty
12

NDC: 0338-0190-04
2F7144

EXP
LOT #

Bar Code
(01)50303380190046(17)080630(10)G012345

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018508	02/19/1982

Labeler - Baxter Healthcare Corporation (005083209)

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

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