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Tis-U-Sol

Generic name: sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate
Dosage form: irrigation solution
Drug class: Sterile irrigating solutions

Medically reviewed by Drugs.com. Last updated on Jan 22, 2021.

Tis-U-Sol 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 for Tis-U-Sol

Isotonic solution for irrigation only. Not for injection.

Tis-U-Sol 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 is Tis-U-Sol 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

Tis-U-Sol
sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0190
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 800 mg in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 40 mg in 100 mL
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 20 mg in 100 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (SODIUM CATION and PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8.75 mg in 100 mL
POTASSIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION and POTASSIUM CATION) POTASSIUM PHOSPHATE, MONOBASIC 6.25 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description
1 NDC:0338-0190-04 12 BOTTLE, PLASTIC in 1 CARTON
1 1000 mL in 1 BOTTLE, PLASTIC
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 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 Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0190)
Baxter Healthcare Corporation

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