Phenytoin Sodium (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Blister Card Label

NDC 58118-4111-8
30 Capsules

Extended
Phenytoin Sodium
Capsules, USP

100 mg

DISPENSE THE
ACCOMPANYING
MEDICATION GUIDE
TO EACH PATIENT.

Keep this and all medications out of the reach of children.

Rx only

Phenytoin Sodium ER 100mg capsule 30 count blister card
(click image for full-size original)
PHENYTOIN SODIUM phenytoin sodium capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-4111(NDC:51672-4111)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
BENZYL ALCOHOL
BUTYLPARABEN
D&C YELLOW NO. 10
EDETATE CALCIUM DISODIUM
FD&C RED NO. 3
GELATIN, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM LAURYL SULFATE
SODIUM PROPIONATE
TITANIUM DIOXIDE
Product Characteristics
Color orange (opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code TARO;PHN;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-4111-8 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040684 03/07/2019
Labeler — Clinical Solutions Wholesale, LLC (078710347)
Registrant — Clinical Solutions Wholesale, LLC (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale, LLC 078710347 repack (58118-4111)

Revised: 09/2020 Clinical Solutions Wholesale, LLC

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