Abacavir (Page 8 of 8)

Warning Card

Front

9202121/0918OS WARNING CARD

Abacavir Tablets USP

Patients taking abacavir tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. If you get a symptom from 2 or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking this medicine.

Back

	Symptom(s)
Group 1	Fever
Group 2	Rash
Group 3	Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
Group 4	Generally ill feeling, extreme tiredness, or achiness
Group 5	Shortness of breath, cough, or sore throat

Package/Label Display Panel – Carton – 300 mg

NDC 68084- 021 -21

Abacavir
Tablets USP

300 mg

30 Tablets (3 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide and Warning Card to each patient.

Each Film-Coated Tablet Contains:
Abacavir sulfate USP equivalent to 300 mg of abacavir.

Usual Dosage: See package insert for full prescribing
information.

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].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 65862-073, Aurobindo Pharma USA, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

002121 0202121/0918OS

Package/Label Display Panel – Blister – 300 mg

Abacavir Tablet USP

300 mg

ABACAVIR abacavir sulfate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-021(NDC:65862-073) 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 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSE 2910 (6 MPA.S) FERRIC OXIDE YELLOW POLYSORBATE 80 TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score 2 pieces Shape CAPSULE (Biconvex) Size 18mm Flavor Imprint Code D;88 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68084-021-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-021-11) 1 NDC:68084-021-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-021-21)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077844 01/24/2013

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (68084-021)

Revised: 11/2019 American Health Packaging