NDC Code(s) : 68220-131-04
Packager : Alaven Pharmaceutical LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRILYTE Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-131
Route of Administration ORAL, NASOGASTRIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyethylene Glycol 3350(UNII: G2M7P15E5P)
(Polyethylene Glycol 3350 - UNII:G2M7P15E5P) 		Polyethylene Glycol 3350420 g in 4 L
sodium chloride(UNII: 451W47IQ8X)
(sodium cation - UNII:LYR4M0NH37) 		sodium chloride11.2 g in 4 L
sodium bicarbonate(UNII: 8MDF5V39QO)
(sodium cation - UNII:LYR4M0NH37) 		sodium bicarbonate5.72 g in 4 L
potassium chloride(UNII: 660YQ98I10)
(potassium cation - UNII:295O53K152) 		potassium chloride1.48 g in 4 L
Product Characteristics
Color WHITE Score
Shape Size
Flavor LEMON, LIME, CHERRY, BERRY, CITRUS, ORANGE, PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68220-131-044 L in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076491 06/24/2004

PRINCIPAL DISPLAY PANEL

NDC 68220-131-04

See base label for mixing information.

Note to pharmacist: Dispense bottle
and all attached flavor packs to patient.
Package insert may be removed before
dispensing.

TriLyte®
with
flavor packs

(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
for oral solution)

Rx Only

4009764   Rev 2E  11/2008   131-1108-01

When reconstituted with water to a volume of 4 liters, this solution
contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L,
bicarbonate 17 mmol/L and potassium 5 mmol/L.

This package contains the following ingredients:
Polyethylene Glycol 3350            420 g
Sodium Bicarbonate                   5.72 g
Sodium Chloride                        11.2 g
Potassium Chloride                    1.48 g

Store in sealed container at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F).

ALAVEN®
PHARMACEUTICAL LLC

4 liters

Principal Display Panel - 4 liter bottle labelPrincipal Display Panel - 4 liter bottle label

PRINCIPAL DISPLAY PANEL

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

lemon lime
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Principal Display Panel - lemon lime flavor pack label

PRINCIPAL DISPLAY PANEL

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

pineapple
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Principal Display Panel - pineapple flavor pack label

PRINCIPAL DISPLAY PANEL

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

citrus berry
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Principal Display Panel - citrus berry flavor pack label

PRINCIPAL DISPLAY PANEL

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

cherry
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Principal Display Panel - cherry flavor pack label

PRINCIPAL DISPLAY PANEL

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

orange
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Principal Display Panel - orange flavor pack label