Ibuprofen (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

72789364 Label
(click image for full-size original)

IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-364(NDC:67877-321)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
POVIDONE K90
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (caplet-shaped tablet) Size 19mm
Flavor Imprint Code I;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-364-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:72789-364-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:72789-364-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:72789-364-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:72789-364-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
6 NDC:72789-364-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
7 NDC:72789-364-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
8 NDC:72789-364-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
9 NDC:72789-364-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
10 NDC:72789-364-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091625 12/21/2015
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-364)

Revised: 03/2024 PD-Rx Pharmaceuticals, Inc.

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