Aleve ®

Aleve ®
SPL v12
SPL
SPL Set ID 3c0ddd25-5a9a-4628-a971-65fe2a9775b5
Route
ORAL
Published
Effective Date 2014-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Purposes

Pain reliever/fever reducer

Directions

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 of age
  • ask a doctor

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information
  • each tablet contains: sodium 20 mg
  • store at room temperature. Avoid excessive heat above 40°C (104°F).
Inactive Ingredients

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

Questions Or Comments?

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

When Using This Product
  • take with food or milk if stomach upset occurs

Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Active Ingredient (in Each Tablet)

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

nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug
Principal Display Panel 320 Tablet Bottle Label

Soft Grip™

Arthritis Caps

ALL DAY STRONG®



ALEVE ®




naproxen sodium tablets, 220 mg (NSAID)



Pain reliever/fever reducer

THIS PACKAGE IS CHILD-RESISTANT

STRENGTH



TO LAST



12 HOURS

320 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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Purposes

Pain reliever/fever reducer

Directions

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 of age
  • ask a doctor

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert (Allergy alert)

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • store at room temperature. Avoid excessive heat above 40°C (104°F).
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs

Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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

nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug
Principal Display Panel 320 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 320 Tablet Bottle Label)

Soft Grip™

Arthritis Caps

ALL DAY STRONG®



ALEVE ®




naproxen sodium tablets, 220 mg (NSAID)



Pain reliever/fever reducer

THIS PACKAGE IS CHILD-RESISTANT

STRENGTH



TO LAST



12 HOURS

320 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)