Normosol-R (Page 3 of 3)


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Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
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Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

PRINCIPAL DISPLAY PANEL — 500 mL Bag Label

500 mL
NDC 0990-7670-03

NORMOSOL® -R pH 7.4
MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP

EACH 100 mL CONTAINS SODIUM CHLORIDE 526 mg; SODIUM ACETATE,
ANHYD. 222 mg; SODIUM GLUCONATE 502 mg; POTASSIUM CHLORIDE
37 mg; MAGNESIUM CHLORIDE, HEXAHYDRATE 30 mg IN WATER FOR INJECTION. MAY
CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT.
ELECTROLYTES PER 1000 mL (NOT INCLUDING pH ADJUSTMENT): SODIUM 140 mEq;
POTASSIUM 5 mEq; MAGNESIUM 3 mEq; CHLORIDE 98 mEq; ACETATE 27 mEq; GLUCONATE
23 mEq.
295 mOsmol/LITER (CALC).
pH 6.5 TO 7.6

ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN
INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE.

SINGLE-DOSE CONTAINER. FOR INTRAVENOUS OR SUBCUTANEOUS USE.USUAL DOSAGE: SEE
INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED
IN SERIES CONNECTIONS.

Rx ONLY

3
v
CONTAINS DEHP

icumedical

IM-4446

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

PRINCIPAL DISPLAY PANEL -- 500 mL Bag Label
(click image for full-size original)
NORMOSOL-R
sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0990-7670
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 526 mg in 100 mL
SODIUM ACETATE ANHYDROUS (SODIUM CATION) SODIUM ACETATE ANHYDROUS 222 mg in 100 mL
SODIUM GLUCONATE (SODIUM CATION) SODIUM GLUCONATE 502 mg in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 37 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 30 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0990-7670-03 24 BAG in 1 CASE contains a BAG
1 500 mL in 1 BAG This package is contained within the CASE (0990-7670-03)
2 NDC:0990-7670-09 12 BAG in 1 CASE contains a BAG
2 1000 mL in 1 BAG This package is contained within the CASE (0990-7670-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017586 09/01/2019
Labeler — ICU Medical Inc. (118380146)

Revised: 01/2022 ICU Medical Inc.

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