aleve ®

aleve ®
SPL v14
SPL
SPL Set ID acea54a2-5a92-428e-a778-bb4f9d676782
Route
oral
Published
Effective Date 2020-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
naproxen (220 mg)
Inactive Ingredients
aluminum oxide d&c yellow no. 10 edetate disodium fd&c blue no. 1 fd&c yellow no. 6 gelatin glycerin hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified povidone stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ALEVE Shape: oval Color: yellow Size: 15 mm Score: 1
Marketing Status
nda active Since 2002-08-01
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 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive Ingredients

D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

Description

Drug Facts

Principal Display Panel

SOFT GRIP® ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

THIS PACKAGE IS

CHILD-RESISTANT

STRENGTH

TO LAST

12 HOURS

40 GELCAPS

GELATIN COATED

CAPSULE-SHAPED TABLETS

Section 42229-5

Drug Facts

Questions Or Comments?

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

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
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 (Other information)

  • each tablet 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)

D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SOFT GRIP® ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

THIS PACKAGE IS

CHILD-RESISTANT

STRENGTH

TO LAST

12 HOURS

40 GELCAPS

GELATIN COATED

CAPSULE-SHAPED TABLETS

Section 42229-5 (42229-5)

Drug Facts

Questions Or Comments? (Questions or comments?)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.952261 · Updated: 2026-03-14T23:11:00.469021