Aleve

Aleve
SPL v3
SPL
SPL Set ID 60637aeb-deb6-4747-e053-2a91aa0ad00b
Route
ORAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: Aleve Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
NDA Active Since 2017-12-04 Until 2024-11-30

Description

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) * *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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
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 50566-9

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
  • 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
Section 50567-7

When using this product

• take with food or milk if stomach upset occurs

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Section 50568-5

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition

• taking any other drug

Section 50569-3

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, or kidney disease

• you are taking a diuretic

• you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma

Section 50570-1

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• right before or after heart surgery

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

Warnings

Allergy alert

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

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

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 chace 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, napoxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time 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 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

Questions Or Comments?

1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com

Active Ingredient (in Each Caplet)

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

*nonsteroidal anti-inflammatory drug

Principal Display Panel 12 Pouch Dispensit


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 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 50566-9 (50566-9)

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
  • 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
Section 50567-7 (50567-7)

When using this product

• take with food or milk if stomach upset occurs

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition

• taking any other drug

Section 50569-3 (50569-3)

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, or kidney disease

• you are taking a diuretic

• you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma

Section 50570-1 (50570-1)

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• right before or after heart surgery

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

Warnings

Allergy alert

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

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

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 chace 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, napoxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time 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 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 (Inactive ingredients)

FD&C blue #2 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) or www.aleve.com

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 12 Pouch Dispensit (PRINCIPAL DISPLAY PANEL - 12 POUCH DISPENSIT)


Advanced Ingredient Data


Raw Label Data

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