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)

image
(click image for full-size original)
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.

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