Abacavir Sulfate: Package Insert and Label Information (Page 6 of 6)

PRINCIPAL DISPLAY PANEL – 300 mg

NDC 0378-4105-91

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 60 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.]

Dispense in original container with
attached prescribing information that
contains the Medication Guide.

Keep container tightly closed.

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Mylan.com

MX:4105:1C:R3

Abacavir Tablets 300 mg Carton Label
(click image for full-size original)
ABACAVIR SULFATE abacavir sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
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:0378-4105-91 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0378-4105-91)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091294 06/19/2012
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 01/2021 Mylan Pharmaceuticals Inc.

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