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IBUPROFEN (ibuprofen 200 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Shasun Pharmaceuticals Limited

Generic: ibuprofen

IBUPROFEN tablet, coated - (ibuprofen 200 mg) image

IMPRINT: IBU200     SHAPE: round
    COLOR: orange

  1. FDA Adverse Reactions

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Otc - Active Ingredient Section

Ibuprofen, USP 200 mg (NSAID)*

____________________________________

* nonsteroidal anti-inflammatory drug

Otc - Purpose Section

Pain reliever / fever reducer

Indications And Usage

■    temporarily relieves minor aches and pains due to:

                ■  headache

                ■  muscular aches

                ■  minor pain of arthritis

                ■  toothache

                ■  backache

                ■  the common cold

                ■  menstrual cramps

■    temporarily reduces fever

Warnings


Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:
  • hives
  • facial swelling
  • rash
  • bulers
  • shock
  • skin reddening
  • asthma (wheezing)
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a non-steroidal anti-inflammatory drug (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

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

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

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

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

Stop use and ask a doctor if

â–  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

â–  pain gets worse or lasts more than 10 days

â–  fever gets worse or lasts more than 3 days

â–  redness or swelling is present in the painful area

â–  any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen 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

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage And Administration

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

Storage And Handling

■ Store between 20-25°C (68-77°F)

â–  tamper evident: do not use if imprinted safety seal under cap is broken or missing;

                                  do not use if seal is open or missing in bulk pack.

Inactive Ingredient

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C Yellow #6 Al.Lake, sodium starch glycolate, titanium dioxide, triacetin and talc

Otc - Questions

Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM

Spl Unclassified

Manufactured by:

Shasun Pharmaceuticals Limited,

Unit-II, R.S. No.: 32, 33, 34,

Shasun Road, Periyakalapet,

Puducherry - 605014, INDIA

See New Warnings Information

Ibuprofen Tablets USP 200 mg

Pain Reliever / Fever Reducer (NSAID)

- 24 coated tablets

- 50 coated tablets

- 100 coated tablets

- 165 coated tablets

- 500 coated tablets

- 1000 coated tablets

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"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."

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"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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