Finasteride 1 MG Oral Tablet
1 INDICATIONS AND USAGE Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women. Finasteride tablets is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). Finasteride tablets is not indicated for use in women ( 1 , 4 , 5.1 ).
Ascend Laboratories, LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
FINASTERIDE tablets, USP 1 mg are available as reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side. They are supplied as follows: 30’s HDPE Container pack: NDC 67877-455-30 90’s HDPE Container pack: NDC 67877-455-90 500’s HDPE Container pack: NDC 67877-455-05 Carton of 30 (3 x 10 unit-dose) Tablets: NDC 67877-455-94 Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Preserve in a tight, light-resistant container. Women should not handle crushed or broken
FINASTERIDE tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of
FINASTERIDE and the subsequent potential risk to a male fetus.
FINASTERIDE tablets, USP 1 mg are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [ see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) and Patient Counseling Information (17)] .
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