Lactated Ringers Injection, Solution
FDA Label NDC 0338-9600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Company for the product Lactated Ringers (NDC 0338-9600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Container Label Ndc 0338-9600-01 (Image 18)

Container Label Ndc 0338-9600-01 (Image 18)

Container Label

JB2324 1000 mL DIN 00061085

Lactated Ringer’s
Injection USP

Lactate de Ringer
USP, Injectable

Lactated Ringer

Lactate de Ringer

APPROX mmol/L Na – 130 K – 4 Ca – 1.4
CI – 109 LACTATE – 28 mOsmol/L – 272 pH 6.5

INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT
RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION
INTRAVENIEUSE

PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310
mg / POTASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE
DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs

PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SO-
DIUM – 310 mg/ CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DE
CHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE
AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE
TREATEMENT OF LACTATE ACIDOSIS / MUST NOT BE USED IN SERIES
CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD
STORE AT 15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER
ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS
LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE
EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG
GARDER ENTRE 15°C ET 25°C

NONPYROGENIC / STERILE / APYROGENE

VIAFLEX PVC CONTAINER / CONTENANT DE PVC

BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
INTERNATIONAL INC

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label

88-70-20-487

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