Ibuprofen

What is Motrin (Ibuprofen) and how is it used?

Motrin is an over the counter medicine used as a pain reliever and fever reducer associated symptoms of inflammatory disease, osteoarthritis, rheumatoid arthritis and menstrual cramps. Motrin may be used alone or with other medications.

Motrin is a nonsteroidal anti-inflammatory drug or NSAIDs.

It is not known if Motrin is safe and effective in children younger than 6 months of age.

What are the possible side effects of Motrin (Ibuprofen)?

Motrin (Ibuprofen) may cause serious side effects including:

• vision changes,
• shortness of breath or feeling light-headed,
• swelling in your hands or feet, face or tongue,
• rapid weight gain,
• skin rash that is red or purple with blisters,
• bloody or tarry stools,
• coughing up blood or vomit that looks like coffee grounds,
• nausea,
• upper stomach pain,
• itching,
• feeling tired,
• flu-like symptoms,
• loss of appetite,
• little or no urinating,
• dark urine,
• clay colored stools,
• yellowing of skin or eyes (jaundice),
• rapid heart rate,
• trouble concentrating,
• fever, and
• burning in your eyes

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Motrin (Ibuprofen) include:

• nausea,
• vomiting,
• gas,
• bleeding,
• dizziness, and
• headache

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Motrin (Ibuprofen). For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Active ingredient (in each brown tablet): Ibuprofen USP
200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

INDICATIONS

Purpose

Pain reliever/fever reducer

Uses

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

DOSAGE AND ADMINISTRATION

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 12 years: ask a doctor

HOW SUPPLIED

Other information

• store between 20°-25°C (68°-77°F)
• avoid excessive heat 40°C (104°F)
• see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday - Friday

Distributed by LNK International Inc., 60 Arkay Drive, Hauppauge, NY 11788 USA. Revised: Apr 2016

SIDE EFFECTS

No information provided.

See WARNINGS Section.

DRUG INTERACTIONS

No information provided.

See 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
• 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:

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• 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

• 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

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
• 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

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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
• redness or swelling is present in the painful area
• 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.

Keep out of reach of children.

PRECAUTIONS

See WARNINGS Section above.

OVERDOSE

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

CONTRAINDICATIONS

No information provided.

CLINICAL PHARMACOLOGY

No information provided.

PATIENT INFORMATION

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
• 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:

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• 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

• 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

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
• 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

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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
• redness or swelling is present in the painful area
• 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.

Keep out of reach of children.