Rilutek (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

RILUTEK 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 70515-700-60.

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.

17 PATIENT COUNSELING INFORMATION

Advise patients to inform their healthcare provider if they experience:

Yellowing of the whites of the eyes [see Warnings and Precautions (5.1)]
Fever [see Warnings and Precautions (5.2)]
Respiratory symptoms—for example, dry cough and difficult or labored breathing [see Warnings and Precautions (5.3)]

Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

©2020, Covis Pharma

LogoLogo

PRINCIPAL DISPLAY PANEL — BOTTLE

Principal Display Panel -- Bottle
(click image for full-size original)

Bottle Label

NDC 70515-700-60

RILUTEK ®

riluzole

Tablets

50 mg

60 Tablets

Covis

Rx Only Each RILUTEK ® Tablet contains 50mg
riluzole. Usual Dosage: One tablet every
12 hours by oral route. See
package insert for full prescribing
information. WARNING:
Keep out of reach of children.

Lot:
Exp.:

Store at controlled room temperature 20-25°C (68-77°F). Protect from bright light.

Mfd. for: Covis Pharma
Zug, 6300 Switzerland ©2016
Made in France Rev. 5/16 100254

RILUTEK
riluzole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-700
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
riluzole (riluzole) riluzole 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MICROCRYSTALLINE CELLULOSE
silicon dioxide
magnesium stearate
croscarmellose sodium
HYPROMELLOSE, UNSPECIFIED
polyethylene glycol 6000
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule-shaped) Size 10mm
Flavor Imprint Code RPR;202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-700-60 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET in 1 BOTTLE This package is contained within the CARTON (70515-700-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020599 08/01/2016
Labeler — Covis Pharma US, Inc (118094829)

Revised: 12/2021 Covis Pharma US, Inc

Page 4 of 4 1 2 3 4

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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.