CARBAMAZEPINE (Page 8 of 8)

PRINCIPAL DISPLAY PANEL Bottle Label

MGP

NDC 60432-129-16

CARBAMAZEPINE

ORAL SUSPENSION,

USP

100 mg/5 mL

IMPORTANT: Shake well before using.

DO NOT USE IF TAMPER-EVIDENT SEAL

IS BROKEN OR MISSING.

PHARMACIST: Dispense with attached

Medication Guides. Provide 1 Medication Guide

to each patient.

Rx Only

NET: 450 mL

Carbamazepine Oral Suspension Label

CARBAMAZEPINE carbamazepine suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-129 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SUCROSE SORBITOL PROPYLENE GLYCOL XANTHAN GUM POTASSIUM SORBATE VANILLIN HYPROMELLOSES ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 WATER TRISODIUM CITRATE DIHYDRATE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60432-129-16 450 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075714 06/05/2002

Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Revised: 12/2018 Morton Grove Pharmaceuticals, Inc.