tenofovir disoproxil fumarate 245 mg
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1) for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. (1.2) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older Pediatric use information is approved for Gilead Sciences, Inc.'s VIREAD® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
REMEDYREPACK INC.
ROUND WHITE TDF
TDF ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Tenofovir Disoproxil Fumarate Tablets 300 mg are white circular film-coated convex tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, engraved TDF on one side and plain on other side and are available in a 40 cc/ 50 cc HDPE container containing a desiccant (silica gel sachet) and closed with child-resistant screw cap. NDC: 70518-1002-00 NDC: 70518-1002-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 4 in 1 BLISTER PACK Store tenofovir disoproxil fumarate tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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