NDC Code(s) : 56062-490-71, 56062-490-78, 56062-490-75
Packager : Publix Super Markets Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

all day reliefNaproxen Sodium TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-490
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
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code L490
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:56062-490-711 in 1 CARTON 15/03/2001
150 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:56062-490-781 in 1 CARTON 29/12/1997
2100 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:56062-490-751 in 1 CARTON 08/09/2022
390 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 ANDA074661 12/29/1997

LABELER - Publix Super Markets Inc(006922009)

PRINCIPAL DISPLAY PANEL

All Day Relief

NAPROXEN SODIUM TABLETS, 220 mg

• Pain reliever/fever reducer (NSAID)

• Strength to last 12 hours

P

ACTUAL SIZE

COMPARE TO ALEVE® TABLETS ACTIVE INGREDIENT

90 Tablets

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