Abacavir Sulfate (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 53808-0627-1

Abacavir
Tablets, USP
300 mg

Notice to Authorized Dispenser:
Each time abacavir tablets are dispensed,
give the patient a Medication Guide and
Warning Card from the carton.

Rx only 30 Tablets

Each film-coated tablet contains
abacavir sulfate, USP equivalent to
300 mg of abacavir.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Abacavir Tablets, USP 300 mg Carton Labels

ABACAVIR SULFATE abacavir sulfate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0627(NDC:0378-4105) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape OVAL (capsule-shaped) Size 18mm Flavor Imprint Code M;120 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53808-0627-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091294 01/01/2013

Labeler — State of Florida DOH Central Pharmacy (829348114)

Establishment
Name	Address	ID/FEI	Operations
State of Florida DOH Central Pharmacy		829348114	repack (53808-0627)

Revised: 08/2013 State of Florida DOH Central Pharmacy