NDC: 63629-7819-1 30 TABLET, FILM COATED in a BOTTLE
NDC: 63629-7819-2 10 TABLET, FILM COATED in a BOTTLE
NDC: 63629-7819-4 40 TABLET, FILM COATED in a BOTTLE
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during letrozole therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with letrozole tablets [see Warnings and Precautions ( 5.6), and Use in Specific Populations ( 8.1), ( 8.3)]
Advise women not to breastfeed during letrozole tablets treatment and for at least 3 weeks after the last dose [see Use in Specific Populations ( 8.2) .
Advise females and males of reproductive potential of the potential for reduced fertility from letrozole tablets [see Use in Specific Populations ( 8.3) .
Fatigue and Dizziness
Since fatigue and dizziness have been observed with the use of letrozole tablets and somnolence was uncommonly reported, caution is advised when driving or using machinery.
Bone Effects Consideration should be given to monitoring bone mineral density.
Accord Healthcare, Inc.,
1009 Slater Road,
Durham, NC 27703,
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210. India.
10 2293 1 697339
Issued May 2019
Letrozole 2.5mg Tablet
|LETROZOLE letrozole tablet, film coated|
|Labeler — Bryant Ranch Prepack (171714327)|
|Bryant Ranch Prepack||171714327||REPACK (63629-7819), RELABEL (63629-7819)|
Revised: 12/2020 Bryant Ranch Prepack
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