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-container-label-90s-count
4mg-container-label-1000s-count
8mg-container-label-30s-count
8mg-container-label-90s-count
8mg-container-label-1000s-count
SILODOSIN silodosin capsule |
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SILODOSIN silodosin capsule |
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Revised: 12/2020 MSN LABORATORIES PRIVATE LIMITED
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.
https://medlibrary.org/lib/rx/meds/silodosin-6/page/5/