IBU (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Ibu™ Ibuprofen Tablets, USP 800mg

20 Tablets

NDC 10544-071-20

Label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Ibu™ Ibuprofen Tablets, USP 400mg

40 Tablets

NDC 10544-625-40

Label
(click image for full-size original)
IBU
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-625(NDC:55111-682)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 8mm
Flavor Imprint Code 4I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-625-40 40 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 01/14/2014
IBU
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-071(NDC:55111-684)
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
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 8I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-071-20 20 TABLET in 1 BOTTLE None
2 NDC:10544-071-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 03/23/2012
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-071), repack (10544-625)

Revised: 02/2015 Blenheim Pharmacal, Inc.

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