Aleve Back & Muscle Pain Ui 1600169

Aleve Back & Muscle Pain Ui 1600169
SPL v19
SPL
SPL Set ID 6376e1b8-52c4-0519-e053-2a91aa0af35f
Route
ORAL
Published
Effective Date 2018-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Magnesium Stearate Talc Titanium Dioxide Povidone Fd&c Blue No. 2 Hypromelloses Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: ALEVE Shape: round Color: blue Size: 8 mm Score: 1
Marketing Status
NDA Active Since 2018-01-26 Until 2021-11-30
Description

Drug Facts

Medication Information

Dosage and Administration

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 tablets 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

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches
    • minor pain of arthritis
    • menstrual cramps
    • headache
    • toothache
    • the common cold
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

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

Section 51727-6

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

Section 53413-1

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Section 55105-1

Purposes

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg)

(NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

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).
Package Label Display

All Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches
    • minor pain of arthritis
    • menstrual cramps
    • headache
    • toothache
    • the common cold
  • temporarily reduces fever
Dosage and Administration (34068-7)

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 tablets 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

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.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg)

(NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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).
Package Label Display (Package label display)

All Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:28.180392 · Updated: 2026-03-14T23:10:57.415546