Motrin Gelcaps: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Since everyone’s pain is different, MOTRIN^® offers 3 levels of pain relief to suit your needs. So you can choose your relief, MOTRIN^® products are available in three strengths, including: MOTRIN^® 200 mg (Regular Strength), MOTRIN^® 300 mg (Extra Strength) and MOTRIN^® 400 mg (Super Strength) Tablets.

MOTRIN^® products provide fast and effective relief of PAIN from:

• headache, including mild to moderate migraine and

  tension headache

• menstrual cramps
• toothache (dental pain), including dental extraction

• inflammation from arthritis, muscle strain, and

  sprains, muscles, bones and joints, including back pain

MOTRIN^® is also an effective fever reducer and will provide relief from the aches and pain due to the common cold and flu.

Clinical studies show long lasting relief for up to 8 hours

for fever and up to 6 hours for pain.

What it does:

MOTRIN^® ibuprofen starts to work fast and treats pain where it starts.

Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by blocking the production of substances, called prostaglandins, which are involved in the development of pain and inflammation.

When it should not be used:

MOTRIN^® should not be used if you:

• are taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication, including any other ibuprofen product.
• are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see non-medicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, rash, swelling of the face or throat or sudden collapse.
• have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
• have been diagnosed with severe high blood pressure or have severe coronary artery disease.
• are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
• have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis)
• have liver or kidney disease.
• have systemic lupus erythematosus.

• are pregnant or nursing, unless advised otherwise by a doctor.

• Right before or after heart surgery

What the medicinal ingredient is:

Ibuprofen

What the important nonmedicinal ingredients are:

MOTRIN^® 200 mg and MOTRIN^® Caplet are white, sweet-coated, easy to swallow tablets and caplets, printed with “Motrin IB” in black ink, contain: colloidal silicon dioxide, corn starch, hypromellose, iron oxide black, polyethylene glycol, pregelatinized starch, propylene glycol, sodium cyclamate, sodium starch glycolate, stearic acid and titanium dioxide.

MOTRIN^® Gelcaps are orange and white gelatin-coated, easy to swallow gelcaps, printed with “Motrin IB” in grey ink, contain: calcium disodium EDTA, castor oil, cellulose, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, gelatin, hypromellose, magnesium stearate, parabens, povidone, propylene glycol, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, synthetic black iron oxide, titanium dioxide.

MOTRIN^® 300 mg (Extra Strength) are light orange, sweet-coated, easy to swallow, tablets, printed with “MOTRIN 300 mg” in black ink, contain: carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, hypromellose, iron oxide black, polydextrose, polyethylene glycol, propylene glycol, sodium cyclamate, sodium starch glycolate, stearic acid, titanium dioxide.

MOTRIN^®400 mg (Super Strength) are orange, sweet-coated, easy to swallow tablets, printed with “MOTRIN 400 mg” in black ink, contain: carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, hypromellose, iron oxide black, polydextrose, polyethylene glycol, propylene glycol, sodium cyclamate, sodium starch glycolate, stearic acid, titanium dioxide.

What dosage forms it comes in:

Tablets: 200 mg, 300 mg, 400 mg

Caplets: 200 mg

Gelcaps: 200 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.

Keep this medication out of the reach of children.

BEFORE you use MOTRIN^® talk to your doctor or pharmacist if you:

• have stomach ulcers, high blood pressure, asthma,

  heart failure, kidney or liver disease, diabetes, alcoholism, a history of stomach bleeding, systemic lupus erythematosus, or any other serious disease or condition.

  • are taking an anticoagulant (blood thinning medication),oral corticosteroid or any other drug.
  • are nursing an infant.
  • are over 65 years of age.
  • are taking low-dose ASA.
  • suffer from asthma or have nasal polyps (a swelling inside the nose).
  • are dehydrated (severe fluid loss).
  • have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.).
  • have a heart disease.

  • have any unusual urinary symptoms (e.g.

    bladder problems).

  • are on a special diet (e.g. low-sodium).
  • suffer from hyperkalemia (high levels of potassium in your blood).

They may recommend an alternative analgesic such as acetaminophen.

Children’s MOTRIN^® formulations are available to treat children under 12 years of age.

INTERACTIONS WITH THIS MEDICATION

Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.

Drugs that may interact with MOTRIN^® include: acetylsalicylic acid (ASA) or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), oral steroids (glucocorticoids), lithium, diabetes medications (hypoglycemics), methotrexate, phenytoin, acetaminophen and digoxin.

Do not use this product if you are taking daily low dose ASA (81-325 mg) without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

PROPER USE OF THIS MEDICATION

Usual dose:

For accurate dosing of each product strength, refer to the dosage table and follow the instructions carefully.

The single oral dose may be taken every 4-6 hours as needed. Do not take more than the maximum daily dose (1200 mg in 24 hours) unless advised by a doctor. Take with food or milk if mild stomach upset occurs with use. MOTRIN^® should not be taken for pain for more than 5 consecutive days or for fever for more than 3 days without first talking to your doctor or dentist.

Use the lowest effective dose for the shortest duration. Do not take this product while taking ASA, other ibuprofen containing products or any other pain or fever medicine.

For effective use of this medicine, unless recommended by your doctor or dentist, DO NOT take:

• more than the recommended number of tablets,

  caplets or gelcaps in each single dose

• a dose more often than every 4-6 hours

• this product longer than the recommended period of

  time

Overdose:

In case of overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, abdominal pain or diarrhea; heartburn, bloating or constipation; fluid retention; skin rash or itching; dizziness; any change in vision; ringing or buzzing in the ears, vomiting any blood or have tarry stools, jaundice (yellowing of the eyes or skin due to liver problems).

If you experience dizziness, blurred vision, or hearing problems while taking MOTRIN^®, please use caution when carrying out activities requiring alertness.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking

MOTRIN^®, contact your doctor or pharmacist.

HOW TO STORE IT

Tablets and caplets: Store at 15 to 30^oC (59 to 86^oF).

Gelcaps: Store at room temperature; avoid high humidity and heat (40ºC or 104ºF).

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by request at www.motrin.ca or by contacting the sponsor, McNeil Consumer Healthcare at:

McNeil Consumer Healthcare

division of Johnson & Johnson Inc.

88 McNabb Street

Markham, Canada

L3R 5L2

? 1 888 6MOTRIN / 1 888 666-8746

Last revised: February 26, 2015

© J&J Inc. 2015