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
(click image for full-size original)

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.

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