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.
15 mL unit dose cups: 50 cups (5 x 10) NDC 60687-258-71

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

DO NOT USE IF SEAL IS BROKEN.

PACKAGING INFORMATION

American Health Packaging unit dose cups (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(80 mg per 15 mL / 50 UD) NDC 60687-258-71 packaged from NDC 54838-556

Distributed by:
American Health Packaging Columbus, OH 43217

8425871/0219F

Package/Label Display Panel – Tray

THEOPHYLLINE
ORAL SOLUTION, USP

Rx Only

FOR INSTITUTIONAL USE ONLY

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

8425871/0219F

Package/Label Display Panel – Cup — 80 mg per 15 mL/15 mL

Rx Only

NDC 60687- 258 -44

Theophylline
Oral Solution, USP

80 mg/15 mL

ALCOHOL FREE

Delivers 15 mL

See package insert for full
prescribing information and storage.

For Institutional Use Only

American Health Packaging Columbus, OH 43217

0425871/0620

THEOPHYLLINE theophylline solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-258(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 red (Clear Red) Score Shape Size Flavor FRUIT (Fruit Flavor) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60687-258-71 5 TRAY in 1 CASE contains a TRAY (60687-258-50) 1 NDC:60687-258-50 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (60687-258-71) and contains a CUP, UNIT-DOSE (60687-258-44) 1 NDC:60687-258-44 15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY (60687-258-50) and a CASE (60687-258-71)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091156 03/31/2017

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (60687-258)

Revised: 09/2020 American Health Packaging