Ibuprofen (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only

NDC 0472-2002-94

Ibuprofen Oral Suspension, USP

100 mg/5 mL

Dosage Cup Included

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

4 FL OZ (118 mL)

image
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IBUPROFEN ibuprofen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-2002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
POLYSORBATE 80
STARCH, CORN
WATER
SODIUM BENZOATE
STRAWBERRY
SUCROSE
XANTHAN GUM
Product Characteristics
Color orange Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-2002-94 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0472-2002-94)
2 NDC:0472-2002-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074978 07/16/2018
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 05/2021 Actavis Pharma, Inc.

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