Abacavir (Page 7 of 7)

(Front of Card)

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.

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

Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.
(Back of Card)

WARNING CARD
Abacavir Tablets USP
If you must stop treatment with abacavir tablets because you have had an allergic reaction to abacavir, NEVER take abacavir tablets or another abacavir-containing medicine (EPZICOM® , TRIUMEQ ® , or TRIZIVIR®) again. If you take abacavir tablets or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.
Please read the Medication Guide for additional information on abacavir tablets.
EPZICOM,TRIUMEQ, and TRIZIVIR are registered trademarks of the ViiV Healthcare group of companies.
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302
IndiaRevised: 05/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

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

ABACAVIR abacavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0547(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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (6 MPA.S)
POLYSORBATE 80
FERRIC OXIDE YELLOW
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:69189-0547-1 1 TABLET, FILM COATED in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077844 02/29/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0547), repack (69189-0547)

Revised: 03/2017 Avera McKennan Hospital

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