NDC Code(s) : 37205-262-71, 37205-262-78
Packager : Cardinal Health (Leader) 37205

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Leader All Day Pain ReliefNaproxen Sodium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-262
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM(UNII: 9TN87S3A3C)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONES(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE (oval) Size 12 mm
Flavor Imprint Code I3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-262-711 in 1 BOX
150 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:37205-262-781 in 1 BOX
2100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 06/25/2012 04/30/2018

PRINCIPAL DISPLAY PANEL

Compare to Aleve® tablets active ingredient †

See New Warnings Information

All Day Pain Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever/Fever Reducer (NSAID)

Caplets


All Day Pain Relief Label Image 1All Day Pain Relief Label Image 1