Abacavir: Package Insert and Label Information (Page 5 of 5)

(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 have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines. 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.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152Revised: 06/2018

Package/Label Display Panel

Abacavir Tablets USP

300 mg

30 Tablets

carton label
(click image for full-size original)
ABACAVIR abacavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6874(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)
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:0904-6874-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6874-04)
2 NDC:0904-6874-06 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6874-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077844 12/17/2012
Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2019 Major Pharmaceuticals

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.