These are concentrated sodium chloride solutions. Infuse slowly with constant observation of patient to avoid pulmonary edema.

Each 100 mL of 3% Sodium Chloride Injection USP contains:

Sodium Chloride USP 3 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1030 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 513     Chloride 513

Each 100 mL of 5% Sodium Chloride Injection USP contains:

Sodium Chloride USP 5 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1710 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 856     Chloride 856

3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.

3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss.

These hypertonic sodium chloride solutions are also indicated for the following clinical conditions.

•  Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids.
•  Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections.
•  Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.

3% and 5% Sodium Chloride Injections USP are contraindicated in the presence of elevated, normal, or only slightly decreased plasma electrolyte concentrations, or when additives of sodium and chloride could be clinically detrimental.

Caution: These are concentrated hypertonic sodium chloride solutions. Infuse very slowly with constant observation of the patient to avoid pulmonary edema.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a well-placed small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be determined to evaluate the need for more sodium chloride.

Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Rx only

Revised: September 2016

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

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

•  Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
•  Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
•  Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove plastic protector from sterile set port at bottom of container.
2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

1. Prepare medication site.
2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in use position and continue administration.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

In Canada, distributed by:

B. Braun of Canada, Ltd.

Scarborough, Ontario M1H 2W4

Y36-002-928   LD-237-3

3% Sodium Chloride

Injection USP

REF L8051

NDC 0264-7805-10



500 mL

EXCEL® CONTAINER



Hypertonic

Y94-003-261  LD-259-2

Each 100 mL contains: Sodium Chloride USP 3 g; Water for Injection USP qs



pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0);     Calc. Osmolarity: 1030 mOsmol/liter



Electrolytes (mEq/liter):     Na+  513;         CI–  513



Sterile, nonpyrogenic. Single dose container.



CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with

                   constant observation of patient to avoid pulmonary edema.



Do not use in series connection. For intravenous use only. Use only if solution is clear

and container and seals are intact.



WARNINGS: 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



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

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862



Y94-003-260

LD-133-3

EXP

LOT

5% Sodium Chloride

Injection USP



REF L8061

NDC 0264-7806-10

DIN 01928007

HK 22618



500 mL

EXCEL® CONTAINER



Hypertonic

Y94-003-269  LD-501-1



Each 100 mL contains: Sodium Chloride USP 5 g; Water for Injection USP qs



pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0) ;    Calc. Osmolarity: 1710 mOsmol/liter



Electrolytes (mEq/liter):     Na+  856;         CI–  856



Sterile, nonpyrogenic. Single dose container.



CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with

                  constant observation of patient to avoid pulmonary edema.



Do not use in series connection. For intravenous use only. Use only if solution is clear

and container and seals are intact.



WARNINGS: 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



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

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862



In Canada, distributed by:

B. Braun of Canada, Ltd.

Scarborough, Ontario M1H 2W4 



Y94-003-262

LD-132-3

EXP

LOT