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Generic: ibuprofen sodium is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity


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Otc - Active Ingredient Section


Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Otc - Purpose Section


Purpose

Pain reliever/ Fever reducer

Indications & Usage Section


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

Warnings Section


Warnings

Allergy alert:


Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • •hives
  • •facial swelling
  • •asthma (wheezing)
  • •shock
  • •skin reddening
  • •rash
  • •bulers

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.

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 before use if

  • •stomach bleeding warning applies to you
  • •you have problems or serious side effects from taking pain relievers or fever reducers
  • •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

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 ibuprofen may decrease this benefit of aspirin
  • •taking any other drug

When using this product

  • •take with food or milk if stomach upset occurs

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
  • •redness or swelling is present in the painful area
  • •any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Dosage & Administration Section


Directions
  • • do not take more than directed
  • • the smallest effective dose should be used
  • •adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • •if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • •do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • •children under 12 years: ask a doctor

Storage And Handling Section


Other information
  • •each tablet contains: sodium 22 mg
  • •read all warnings and directions before use.
  • •store at 20-25°C (68-77°F)
  • •avoid excessive heat above 40°C (104°F)

Inactive Ingredient Section


Inactive ingredients

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

Otc - Questions Section


Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

Additional Information


Do Not Use if the sealed child resistant pouch is broken or torn.

For most recent product information, visit www.Advil.com

For US Patent or Application status see www.productpats.com

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies

©2021 GSK group of companies or its licensor

Principal Display Panel


NDC 0573-0133-02

Advil

FILM-COATED IBUPROFEN SODIUM

Ibuprofen Tablets, 200 mg (Provided as Ibuprofen Sodium 256 mg) Pain Reliever / Fever Reducer (NSAID)

Advil Tablets
  • • Headache
  • • Muscular Aches
  • • Minor Pain of Arthritis
  • • Menstrual Cramps
  • • Toothache
  • • Fever

See Full Drug Facts information on the back of this dispenser

100 TABLETS

(50 PACKETS of 2 TABLETS EACH)

000068427 Front Carton

Principal Display Panel


Advil®

20 FREE TABLETS

Ibuprofen Tablets, 200 mg(Provided as Ibuprofen Sodium 256 mg)Pain Reliever / Fever Reducer (NSAID)

FILM-COATEDIBUPROFENSODIUM

Advil Tablets

100 Tablets

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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