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FDA Drug information

Lactated Ringers

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Description

DESCRIPTION Lactated Ringer’s Irrigation Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

Dosage And Administration

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.

Indications And Usage

INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.

Effective Time

20120612

Version

7

Spl Product Data Elements

Lactated Ringers sodium chloride, sodium lactate, potassium chloride, calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE LACTIC ACID SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER

Application Number

NDA018494

Brand Name

Lactated Ringers

Generic Name

sodium chloride, sodium lactate, potassium chloride, calcium chloride

Product Ndc

0338-0114

Product Type

HUMAN PRESCRIPTION DRUG

Route

IRRIGATION

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label Container Label 2F7154 NDC 0338-0114-04 1000 mL Baxter Logo Not for Injection Lactated Ringer's Irrigation Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 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 LOT EXP FPO (91)0709000249 Bar Code 07-09-00-0249 Bar Code Position Only* 303380114047 Lactated Ringer's Irrigation Representative Container Label

How Supplied

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

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