aleve ®

aleve ®
SPL v17
SPL
SPL Set ID a3745850-3e32-4884-b315-161bcb9996ed
Route
oral
Published
Effective Date 2014-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: Aleve Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
nda active Since 2014-02-26 Until 2020-01-30
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

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 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

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)

Active Ingredient (in Each Caplet)

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

nonsteroidal anti-inflammatory drug

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

Structured Label Content

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 (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 (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)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

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

nonsteroidal anti-inflammatory drug

Principal Display Panel 24 Caplet Bottle Carton (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.924704 · Updated: 2026-03-14T23:10:57.415546