NDC Code(s) : 0280-6010-24, 0280-6010-50, 0280-6010-01, 0280-6010-02, 0280-6010-03, 0280-6010-04, 0280-6010-06, 0280-6010-05, 0280-6010-07, 0280-6010-09, 0280-6010-10
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AleveNAPROXEN SODIUM TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-6010
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color blue (light blue) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-6010-241 in 1 CARTON 26/07/2002
124 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0280-6010-501 in 1 CARTON 26/07/2002
250 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:0280-6010-011 in 1 CARTON 26/07/2002
3100 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:0280-6010-021 in 1 CARTON 26/07/2002
4130 in 1 BOTTLE Type 0: Not a Combination Product
5NDC:0280-6010-031 in 1 CARTON 26/07/2002
5150 in 1 BOTTLE Type 0: Not a Combination Product
6NDC:0280-6010-041 in 1 CARTON 26/07/2002
636 in 1 BOTTLE Type 0: Not a Combination Product
7NDC:0280-6010-06225 in 1 BOTTLE Type 0: Not a Combination Product26/07/2002
8NDC:0280-6010-051 in 1 CARTON 26/07/2002
865 in 1 BOTTLE Type 0: Not a Combination Product26/07/2002
9NDC:0280-6010-07270 in 1 BOTTLE Type 0: Not a Combination Product26/07/2002
10NDC:0280-6010-0990 in 1 BOTTLE Type 0: Not a Combination Product26/07/2002
11NDC:0280-6010-101 in 1 TRAY 26/07/2002
1110 in 1 BOTTLE Type 0: Not a Combination Product26/07/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020204 07/26/2002

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

Aleve Tablets - 24 Count Carton ALL DAY STRONG ®

ALEVE ®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

ACTUAL SIZE
24 TABLETS