SILODOSIN (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

White, opaque, hard gelatin 8 mg capsules. Cap is imprinted with “S” in black ink. Body is imprinted with “8 mg”. 8 mg capsules are supplied as:

• 30 capsules (NDC 72205-010-30)
• 90 capsules (NDC 72205-010-90)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.
White, opaque, hard gelatin 4 mg capsules. Cap is imprinted with “S” in black ink. Body is imprinted with “4mg”. 4 mg capsules are supplied as:

• 30 capsules (NDC 72205-009-30)

Bottles of 30 capsules are supplied with child-resistant closures.
Storage
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP controlled room temperature.] Protect from light and moisture.
Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise patients to take silodosin once daily with a meal [see Dosage and Administration (2.1)].
Advise patients about the possible occurrence of symptoms related to postural hypotension (such as dizziness), and should be cautioned about driving, operating machinery, or performing hazardous tasks until they know how silodosin will affect them. This is especially important for those with low blood pressure or who are taking antihypertensive medications [see Warnings and Precautions (5.1)].
Counsel patients on that the most common side effect seen with silodosin is an orgasm with reduced or no semen. This side effect does not pose a safety concern and is reversible with discontinuation of the product [see Adverse Reactions (6.1)].
Counsel patients to tell their ophthalmologist about the use of silodosin before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking silodosin [see Warnings and Precautions (5.7)].

Rx only

Manufactured by:

MSN Laboratories Private Limited
Telangana – 509 228,
INDIA
Distributed by:
Novadoz Pharmaceuticals LLC
Piscataway, NJ 08854-3714
Issued on: January 2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4mg-container-label-30s-count

8mg-container-label-30s-count

8mg-container-label-90s-count

SILODOSIN silodosin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-009 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILODOSIN (SILODOSIN) SILODOSIN 4 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE MANNITOL POLYSORBATE 80 TITANIUM DIOXIDE SHELLAC PROPYLENE GLYCOL POTASSIUM HYDROXIDE GELATIN FERROSOFERRIC OXIDE STARCH, CORN MAGNESIUM ALUMINOMETASILICATE TYPE IA

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code S;4mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72205-009-30 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210687 12/03/2018

SILODOSIN silodosin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILODOSIN (SILODOSIN) SILODOSIN 8 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE MANNITOL POLYSORBATE 80 TITANIUM DIOXIDE SHELLAC PROPYLENE GLYCOL POTASSIUM HYDROXIDE GELATIN FERROSOFERRIC OXIDE STARCH, CORN MAGNESIUM ALUMINOMETASILICATE TYPE IA

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code S;8mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72205-010-30 30 CAPSULE in 1 BOTTLE None 2 NDC:72205-010-90 90 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210687 12/03/2018

Labeler — Novadoz Pharmaceuticals LLC (081109687)

Registrant — Novadoz Pharmaceuticals LLC (081109687)

Establishment
Name	Address	ID/FEI	Operations
MSN LABORATORIES PRIVATE LIMITED		650786952	ANALYSIS (72205-009), ANALYSIS (72205-010), MANUFACTURE (72205-009), MANUFACTURE (72205-010)

Revised: 07/2021 Novadoz Pharmaceuticals LLC