Letrozole (Page 9 of 9)
16 HOW SUPPLIED/STORAGE AND HANDLING
Product: 63629-7819
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
17 PATIENT COUNSELING INFORMATION
Embryo-Fetal Toxicity
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)]
Lactation
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) .
Infertility
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.
Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
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) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (63629-7819), RELABEL (63629-7819) | |
Revised: 12/2020 Bryant Ranch Prepack
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.