NDC Code(s) : 37205-402-62
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Leader IbuprofenIbuprofen TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM) 		IBUPROFEN100 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SOYBEAN OIL(UNII: 241ATL177A)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 13 mm
Flavor ORANGE Imprint Code L461
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-402-621 in 1 CARTON
124 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076359 05/28/2004

PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION

Compare to Motrin® Junior Strength active ingredient

For Ages 2-11

Junior Strength

Ibuprofen Tablets 100 mg

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Orange Flavor

Ibuprofen Tablets 100 mg Carton Image 1Ibuprofen Tablets 100 mg Carton Image 1 Ibuprofen Tablets 100 mg Carton Image 1Ibuprofen Tablets 100 mg Carton Image 2