Aleve ® Headache Pain

Aleve ® Headache Pain
SPL v4
SPL
SPL Set ID c69f4926-c5cd-63a0-e053-2a95a90a2ca6
Route
ORAL
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ALEVE Shape: round Color: blue Size: 8 mm Score: 1
Marketing Status
NDA Active Since 2021-06-01

Description

Naproxen Sodium 220mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Naproxen Sodium 220mg

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

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

Purposes:

Pain reliever/fever reducer

Warnings:

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.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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
Do Not Use:
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Ask A Doctor:
  • 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
Active Ingredient

Naproxen Sodium 220mg

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 Ingredient

FD&C BLUE #2 LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE

Questions & Comments:

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

When Using This Product
  • take with food or milk if stomach upset occurs
Stop Use and Ask A Doctor
  • 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
Keep Out of Reach of Children:

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

Ask A Doctor Or Pharmacist Before Use
  • 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
The Pregnancy/breast Feeding Warning:

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Package Label Principal Display Panel 24 Count Tablets

ALL DAY STRONG®

ALEVE

HEADACHE PAIN

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of headache pain

ACTUAL SIZE

STRENGTH TO LAST 12 HOURS

TABLETS


Structured Label Content

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

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

Purposes:

Pain reliever/fever reducer

Warnings:

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.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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
Do Not Use:
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Ask A Doctor: (Ask a Doctor:)
  • 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
Active Ingredient

Naproxen Sodium 220mg

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 Ingredient (Inactive ingredient)

FD&C BLUE #2 LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE

Questions & Comments: (Questions & 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
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • 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
Keep Out of Reach of Children: (Keep out of reach of children:)

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

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • 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
The Pregnancy/breast Feeding Warning: (The pregnancy/breast-feeding warning:)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Package Label Principal Display Panel 24 Count Tablets (PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 24 Count Tablets)

ALL DAY STRONG®

ALEVE

HEADACHE PAIN

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of headache pain

ACTUAL SIZE

STRENGTH TO LAST 12 HOURS

TABLETS


Advanced Ingredient Data


Raw Label Data

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