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

300 mg Abacavir Tablets Carton
(click image for full-size original)

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

300 mg Abacavir Tablet Blister
(click image for full-size original)

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)
Image of Product
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

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