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  5. Label Information: Bayer Aleve

FDA Label for Bayer Aleve

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DOSAGE & ADMINISTRATION
    14. OTHER SAFETY INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bayer Aleve Product Label

The following document was submitted to the FDA by the labeler of this product Acme United Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active ingredient (in each caplet)

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

*nonsteroidal anti-inflammatory drug


Otc - Purpose



Purposes

Pain reliever/fever reducer


Indications & Usage



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

Warnings



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


Otc - Do Not Use



Do not use

  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Otc - Ask Doctor



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

Otc - Ask Doctor/Pharmacist



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

Otc - When Using



When using this product

  • take with food or milk if stomach upset occurs

Otc - Stop Use



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 for more than 10 days
      • fever gets worse or lasts for 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

Otc - Pregnancy Or Breast Feeding



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.


Otc - 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.


Dosage & 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 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 exceedc3 caplets in a 24- hour period.

      • Children under 12 years:

      ask a doctor


Other Safety Information



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?



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