NDC Code(s) : 41520-604-62, 41520-604-71, 41520-604-78, 41520-604-85, 41520-604-90, 41520-604-76, 41520-604-93, 41520-604-82
Packager : American Sales Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

care one ibuprofenIbuprofen TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM) 		IBUPROFEN200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41520-604-621 in 1 CARTON 13/04/2004
124 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:41520-604-711 in 1 CARTON 13/04/2004
250 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:41520-604-781 in 1 CARTON 13/04/2004
3100 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:41520-604-85250 in 1 BOTTLE Type 0: Not a Combination Product30/11/2017
5NDC:41520-604-90500 in 1 BOTTLE Type 0: Not a Combination Product13/04/2004
6NDC:41520-604-761 in 1 CARTON 06/01/2004
6120 in 1 BOTTLE Type 0: Not a Combination Product13/04/2004
7NDC:41520-604-931000 in 1 BOTTLE Type 0: Not a Combination Product30/11/2017
8NDC:41520-604-822 in 1 CARTON 13/04/2004
8100 in 1 BOTTLE Type 0: Not a Combination Product30/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072096 04/13/2004

LABELER - American Sales Company(809183973)

PRINCIPAL DISPLAY PANEL

CAREone®

family size

Compare to the active ingredient in Advil® Ibuprofen Tablets

IBUPROFEN Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

Gluten Free

Actual Size

See Revised Warning

OUR PHARMACISTS RECOMMEND

500 TABLETS

Ibuprofen Label