Theophylline (Page 6 of 6)

HOW SUPPLIED

THEOPHYLLINE ORAL SOLUTION, USP is a clear red solution with a fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous.
THEOPHYLLINE ORAL SOLUTION, USP is available in bottles of 473 mL

NDC 54838-556-80

RECOMMENDED STORAGE
Store at 20° to 25°C (68° to 77°); [see USP Controlled Room Temperature].Dispense in tight container.

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

10-1110

Rev. 06/21

label
(click image for full-size original)
THEOPHYLLINE theophylline solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54838-556
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THEOPHYLLINE ANHYDROUS (THEOPHYLLINE ANHYDROUS) THEOPHYLLINE ANHYDROUS 80 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SACCHARIN SODIUM
SODIUM BENZOATE
GLYCERIN
PROPYLENE GLYCOL
FD&C RED NO. 40
WATER
Product Characteristics
Color Score
Shape Size
Flavor FRUIT (Fruit Flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54838-556-80 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091156 04/13/2011
Labeler — Lannett Company, Inc. (002277481)

Revised: 06/2021 Lannett Company, Inc.

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