Griseofulvin (Page 2 of 2)

HOW SUPPLIED

Griseofulvin Oral Suspension 125 mg per 5 mL in bottles of 4 fl oz (120 mL) (NDC 54868-5234-0).

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

STORE AT ROOM TEMPERATURE

For more information call 1-800-510-0383.

Manufactured by:
Ortho-McNeil Pharmaceutical, Inc.
Raritan, NJ 08869

Distributed by:
Patriot Pharmaceuticals, LLC
Plymouth Meeting, PA 19462

Printed in U.S.A., © OMP 2005

Revised July 2005
10094000

Relabeling of “Additional Barcode Label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL — 5 mL Label

Griseofulvin
Oral Suspension
(microsize)
125 mg/5 mL

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

Rx Only.

Store at room temperature.

SHAKE BEFORE USING

Pharmacist: This product is protected by a tamper-
resistant seal around the neck opening. If the seal
has been broken or is removed, do not use the product. Return the product to place of purchase.

4 fl oz (120 mL)

image of package label
(click image for full-size original)

GRISEOFULVIN griseofulvin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5234(NDC:10147-0810)
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5234-0 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062483 01/16/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2010 Physicians Total Care, Inc.

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