FDA Label for Lactated Ringers
View Indications, Usage & Precautions
Lactated Ringers 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
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.
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
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, non-
pyrogenic. 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
Bar Code
Position
Only*
303380114047
LOT
EXP
07-09-64-077
Lactated Ringer's
Irrigation
Pour
Bottle
1000 mL
Qty
12
NDC 0338-0114-04
2F7154
EXP
LOT#
(01)50303380114042(17)080630(10)G012345
07-06-47-995
* Please review the disclaimer below.