Drug Facts

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1

1: nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
temporarily reduces fever

Directions

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose

Adults and children 12 years and older	take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8- to 12-hour period do not exceed 3 caplets in a 24-hour period
Children under 12 years	ask a doctor

Other information

each caplet contains: sodium 20 mg
store at 20-25 ° C (68-77 ° F). Avoid high humidity and excessive heat above 40 ° C (104 ° F).

Inactive ingredients

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon - Fri 9AM - 5PM EST)

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

ALL DAY STRONG ®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

ACTUAL SIZE

24 CAPLETS

CAPSULE-SHAPED TABLETS

Aleve Caplets - 24 Count Carton

ALEVE CAPLETS
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0280-6000
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL (capsule shaped tablets)	Size	12mm
Flavor		Imprint Code	Aleve
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0280-6000-06	1 in 1 CARTON	02/26/2014
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0280-6000-24	1 in 1 CARTON	02/26/2014
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0280-6000-50	1 in 1 CARTON	02/26/2014
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:0280-6000-10	1 in 1 CARTON	02/26/2014	06/30/2022
4		100 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:0280-6000-15	1 in 1 CARTON	02/26/2014	07/31/2020
5		150 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:0280-6000-02	1 in 1 CARTON	03/26/2014
6		200 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:0280-6000-27	270 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
8	NDC:0280-6000-32	1 in 1 CARTON	02/26/2014
8		320 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:0280-6000-70	1 in 1 CARTON	03/18/2016
9		150 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:0280-6000-75	1 in 1 CARTON	03/18/2016	01/30/2020
10		180 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:0280-6000-01	24 in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2014
12	NDC:0280-6000-03	1 in 1 CARTON	02/26/2014
12		130 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:0280-6000-04	1 in 1 CARTON	02/26/2014
13		225 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:0280-6000-05	1 in 1 CARTON	02/26/2014
14		36 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC:0280-6000-07	48 in 1 POUCH; Type 0: Not a Combination Product	02/26/2014
16	NDC:0280-6000-08	1 in 1 CARTON	02/26/2014
16		65 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC:0280-6000-12	1 in 1 CARTON	07/01/2021
17		90 in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC:0280-6000-09	1 in 1 POUCH; Type 0: Not a Combination Product	07/01/2020
19	NDC:0280-6000-16	1 in 1 POUCH; Type 0: Not a Combination Product	07/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020204	02/26/2014

Labeler - Bayer HealthCare LLC. (112117283)

Aleve ® Caplets