NDC Code(s) : 0264-7751-00, 0264-7751-10
Packager : B. Braun Medical Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-7751
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE0.6 g in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE0.31 g in 100 mL
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(CHLORIDE ION - UNII:Q32ZN48698) 		POTASSIUM CHLORIDE0.03 g in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE0.02 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0264-7751-0012 in 1 CASE 24/02/1988
11000 mL in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0264-7751-1024 in 1 CASE 24/02/1988
2500 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019634 02/24/1988

LABELER - B. Braun Medical Inc.(002397347)

PRINCIPAL DISPLAY PANEL

5% Dextrose in
Lactated Ringer's
Injection

REF L7510
NDC 0264-7751-00
1000 mL
EXCEL ® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium
Chloride USP 0.6 g; Sodium Lactate 0.31 g; Potassium Chloride
USP 0.03 g; Calcium Chloride•2H2O USP 0.02 g; Water for
Injection USP qs

pH adjusted with HCl NF
pH: 4.6 (4.0-6.0); Calc. Osmolarity: 530 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter):   Na+ 130;    K+ 4;     Ca++ 3;
                                        Cl– 112;     Lactate 28

Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear
and container and seals are intact.

WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
Do Not Administer Simultaneously With Blood. Some additives may
be incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive
heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

recycle symbol

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-220   LD-141-4

EXP
LOT

recycle symbol

PRINCIPAL DISPLAY PANEL

5% Dextrose in
Lactated Ringer's Injection

REF L7511
NDC 0264-7751-10

500 mL
EXCEL ® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride
USP 0.6 g; Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g;
Calcium Chloride•2H2O USP 0.02 g; Water for Injection USP qs

pH adjusted with HCl NF
pH: 4.6 (4.0-6.0); Calc. Osmolarity: 530 mOsmol/liter, hypertonic
Electrolytes (mEq/liter):   Na+ 130;     K+ 4;     Ca++ 3;     Cl– 112;     Lactate 28

Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For
intravenous use only. Use only if solution is clear and container and seals are intact.

WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
Do Not Administer Simultaneously With Blood. Some additives may be
incompatible. Consult with pharmacist. When introducing additives, use aseptic
techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect
from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check for
minute leaks by squeezing container firmly. If leaks are found, discard solution
as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

recycle symbol

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-222
LD-140-4

EXP
LOT

recycle symbol