aleve ®

aleve ®
SPL v19
SPL
SPL Set ID 00ef5b30-71d0-4cb4-84a3-48c67d1cea2a
Route
oral
Published
Effective Date 2014-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
naproxen (220 mg)
Inactive Ingredients
cellulose, microcrystalline polyethylene glycol, unspecified povidone talc titanium dioxide fd&c blue no. 2 hypromelloses magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: ALEVE Shape: round Color: blue Size: 8 mm Score: 1
Marketing Status
nda active Since 2002-07-26
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Active Ingredient

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

nonsteroidal anti-inflammatory drug

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
Purpose

Pain reliever/fever reducer

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 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
  • Children under 12 years
  • ask a doctor

Other Information

  • each tablet contains: sodium 20 mg
  • store at 20-25ºC (68-77ºF). 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Purposes

Pain reliever/fever reducer

Questions Or Comments?

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

Principal Display Panel 24 Tablet Bottle Carton

ALL DAY STRONG ®



ALEVE ®



naproxen sodium tablets, 220 mg (NSAID)



Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

ACTUAL SIZE

24 TABLETS

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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

nonsteroidal anti-inflammatory drug

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 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
  • Children under 12 years
  • ask a doctor

Other Information (Other information)

  • each tablet contains: sodium 20 mg
  • store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purposes

Pain reliever/fever reducer

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel 24 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton)

ALL DAY STRONG ®



ALEVE ®



naproxen sodium tablets, 220 mg (NSAID)



Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

ACTUAL SIZE

24 TABLETS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:27.225037 · Updated: 2026-03-14T23:10:53.901398