TIS-U-SOL description, usages, side effects, indications, overdosage, supplying and lots more!

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TIS-U-SOL

Baxter Healthcare Corporation


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

TIS-U-SOL INDICATIONS AND USAGE

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 SUPPLIED

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

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

TIS-U-SOL

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 (07-06-47-994)

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 800 mg
potassium chloride 40 mg
Magnesium Sulfate Heptahydrate MAGNESIUM CATION 20 mg
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM CATION 8.75 mg
POTASSIUM PHOSPHATE, MONOBASIC 6.25 mg

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1000 in 1 BOTTLE, PLASTIC
2 NDC:0338-0190-04 12 in 1 CARTON

Marketing Information

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


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