(Front of 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)
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.
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Aurobindo Pharma Limited
Mahaboob Nagar (Dt)-509302
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
| 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 || |
|# ||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
| 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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