Griseofulvin (Page 3 of 3)

HOW SUPPLIED

Griseofulvin Oral Suspension USP (microsize), 125 mg per 5 mL is an orange-vanilla flavored suspension available in bottles of 4 fl oz (120 mL) NDC 0472-0013-04.

Dispense Griseofulvin Oral Suspension, USP in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Distributed by:
Actavis Pharma, Inc.Parsippany, NJ 07054 USA

Rev. B 4/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0013-04

Rx Only

Griseofulvin Oral Suspension, USP (microsize)

125 mg/5 mL

Each 5 mL (one teaspoonful) contains 125 mg griseofulvin in a palatable suspension, colored orange. Also contains alcohol 0.2%.

SHAKE BEFORE USING

4 FL OZ (120 mL)

GRISEOFULVIN griseofulvin suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0013 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 125 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL DOCUSATE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM ALUMINUM SILICATE MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SACCHARIN SODIUM SODIUM ALGINATE SUCROSE WATER

Product Characteristics Color Score Shape Size Flavor ORANGE, VANILLA Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0472-0013-04 120 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065394 07/26/2007

Labeler — Actavis Pharma, Inc. (119723554)

Revised: 04/2020 Actavis Pharma, Inc.