Prescribing information (package insert) - 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
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.
About this document
Source: FDA drug labeling via NLM DailyMed · Application number: NDA 018508
· View the label on DailyMed
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The information on this site does not replace the advice of a doctor or pharmacist.
Drug information for Tis-U-Sol
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Calculi Dissolution Agent, Osmotic Laxative, Potassium Salt |
| Active ingredients |
Sodium chloride 800 mg/100 mL,
Potassium chloride 40 mg/100 mL,
Magnesium sulfate heptahydrate 20 mg/100 mL,
Sodium phosphate, dibasic, heptahydrate 8.75 mg/100 mL,
Monobasic potassium phosphate 6.25 mg/100 mL
|
| Dosage form |
Irrigant |
| Route |
Irrigation |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
BAXTER HLTHCARE |
| FDA approval |
NDA 018508New Drug Application (NDA)
Approved February 19, 1982
|
| Therapeutic equivalence (TE) code |
ATCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book). |
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
800 mg/100 mL, 40 mg/100 mL, 20 mg/100 mL, 8.75 mg/100 mL, 6.25 mg/100 mL – 1000 ml in 1 bottle, plastic / 12 in 1 carton
NDC 0338-0190-04
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
