Ibuprofen (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53217-0364 Rx Only

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

53217-0364_IBUPROFEN_600MG
(click image for full-size original)

53217-0364_IBUPROFEN_600MG

IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-364(NDC:67877-320)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
STARCH, CORN
POVIDONE K90
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (caplet-shaped tablet) Size 17mm
Flavor Imprint Code I;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-364-28 28 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091625 05/14/2018
Labeler — Aidarex Pharmaceuticals LLC (801503249)
Establishment
Name Address ID/FEI Operations
Aidarex Pharmaceuticals 801503249 REPACK (53217-364)

Revised: 08/2018 Aidarex Pharmaceuticals LLC

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