FDA Label for Tis-u-sol
View Indications, Usage & Precautions
Tis-u-sol Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
* Please review the disclaimer below.