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 69539-053-30)
  • 90 capsules (NDC 69539-053-90)
  • 1000 capsules (NDC 69539-053-99)

Bottles of 30 and 90 capsules are supplied with child-resistant closures. and 1000 capsules with continuous thread 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 69539-052-30)
  • 90 capsles (NDC 69539-052-90)
  • 1000 capsules (NDC 69539-052-99)

Bottles of 30 and 90 capsules are supplied with child-resistant closures. and 1000 capsules with continuous thread 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:
MSN Pharmaceuticals Inc.
Piscataway, NJ 08854-3714
Issued on: December 2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4mg-container-label-30s-count

4mg-30s
(click image for full-size original)

4mg-container-label-90s-count

4mg-90s
(click image for full-size original)

4mg-container-label-1000s-count

4mg-1000s
(click image for full-size original)

8mg-container-label-30s-count

8mg-30s
(click image for full-size original)

8mg-container-label-90s-count

8mg-90s
(click image for full-size original)

8mg-container-label-1000s-count

8mg-1000s
(click image for full-size original)
SILODOSIN silodosin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69539-052
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:69539-052-30 30 CAPSULE in 1 BOTTLE None
2 NDC:69539-052-90 90 CAPSULE in 1 BOTTLE None
3 NDC:69539-052-99 1000 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:69539-053
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:69539-053-30 30 CAPSULE in 1 BOTTLE None
2 NDC:69539-053-90 90 CAPSULE in 1 BOTTLE None
3 NDC:69539-053-99 1000 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 — MSN LABORATORIES PRIVATE LIMITED (650786952)
Establishment
Name Address ID/FEI Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS (69539-052), ANALYSIS (69539-053), MANUFACTURE (69539-052), MANUFACTURE (69539-053)

Revised: 12/2020 MSN LABORATORIES PRIVATE LIMITED

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