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

80 mg/15 mL Theophylline Oral Solution
(click image for full-size original)

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

Cup Lid -- 80 mg per 15 mL/15 mL
(click image for full-size original)

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

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