Theophylline in Dextrose (Page 8 of 8)

HOW SUPPLIED

Theophylline in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in EXCEL® Containers. The 500 mL containers are packaged 24 per case.

NDC REF Solution Total Dose/Volume
0264-9554-10 P5541 0.08% Theophylline in 5% Dextrose Injection USP 400 mg/500 mL

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: January 2016

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

Directions for Use of EXCEL® Container

Do not admix with other drugs.

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.

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.

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

Y36-002-921 LD-238-4

PRINCIPAL DISPLAY PANEL — 500 mL Container Label

Theophylline in
5% Dextrose Injection USP

REF P5541
NDC 0264-9554-10

500 mL
EXCEL® CONTAINER

THEOPHYLLINE
400 mg (0.8 mg/mL)
Y94-003-341
LD-269-4

Each 100 mL contains: Theophylline, Anhydrous, USP 80 mg; Hydrous Dextrose
USP 5 g; Water for Injection USP, qs

pH: 4.7 (3.5-6.5); Calc. Osmolarity: 255 mOsmol/liter

WARNING: DO NOT ADMIX WITH OTHER DRUGS. DO NOT ADMINISTER
SIMULTANEOUSLY WITH BLOOD. DO NOT USE IN SERIES CONNECTION.

Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is
clear and container and seals are intact.

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

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
API from Germany
Y94-003-325
LD-125-4

EXPLOT

500 ml Container Label P5541
(click image for full-size original)
THEOPHYLLINE IN DEXTROSE theophylline anhydrous and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-9554
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THEOPHYLLINE ANHYDROUS (THEOPHYLLINE ANHYDROUS) THEOPHYLLINE ANHYDROUS 80 mg in 100 mL
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-9554-10 24 CONTAINER in 1 CASE contains a CONTAINER
1 500 mL in 1 CONTAINER This package is contained within the CASE (0264-9554-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019826 08/14/1992
Labeler — B. Braun Medical Inc. (002397347)

Revised: 08/2017 B. Braun Medical Inc.

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