What is ibuprofen and pseudoephedrine?
Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen works by reducing hormones that cause inflammation and pain in the body.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated
blood vessels can cause nasal congestion (stuffy nose).
The combination of ibuprofen and pseudoephedrine is used to treat stuffy nose, sinus
congestion, cough, and pain or fever caused by the common cold or flu.
Ibuprofen and pseudoephedrine may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking ibuprofen and pseudoephedrine?
Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as
isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or
tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if
you take ibuprofen and pseudoephedrine before the MAO inhibitor has cleared from your body.
Taking an NSAID can increase your risk of life-threatening heart or circulation problems,
including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this
medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or
CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including
bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects
can occur without warning at any time while you are taking an NSAID. Older adults may have an even
greater risk of these serious gastrointestinal side effects.
You should not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if
you have:
Ask a doctor or pharmacist about taking ibuprofen and pseudoephedrine if
you have:
-
a history of stomach ulcers or bleeding;
-
heart disease, congestive heart failure, high blood pressure;
-
systemic lupus erythematosus (SLE);
-
liver or kidney disease;
-
a thyroid disorder;
-
diabetes;
-
enlarged prostate or problems with urination;
-
a bleeding or blood clotting disorder; or
-
if you smoke.
FDA pregnancy category B. This medication is not expected to be
harmful to an unborn baby during early pregnancy.
However,
taking ibuprofen and
pseudoephedrine during the last 3 months of pregnancy may result in birth defects and prolonged labor
and delivery. Do not take ibuprofen and pseudoephedrine during the last 3 months of pregnancy unless
your doctor has told you to.
It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it
could harm a nursing baby. Do not use this medication without telling your doctor if you are
breast-feeding a baby.
Do not give this medication to a child younger than 2 years old. Ask a doctor before giving
ibuprofen and pseudoephedrine to any child who has asthma.
How should I take ibuprofen and pseudoephedrine?
Use this medication exactly as directed on the label, or as it has been prescribed by your
doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold
medicine is usually taken only for a short time until your symptoms clear up.
Always ask a doctor before giving a cough or cold medicine to a child.
Death can occur from the misuse of cough and cold medicines in very young children.
Do not take more of this medication than is recommended. An overdose of ibuprofen can
cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800
milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of
ibuprofen and pseudoephedrine needed to get relief from your pain, fever, or cold symptoms.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get
the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular
table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms,
or if your condition does not improve after taking this medication for 7 days.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold
medicine within the past few days.
Store ibuprofen and pseudoephedrine at room temperature away from moisture and heat.
What happens if I miss a dose of ibuprofen and pseudoephedrine?
Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If
you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost
time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled
time.
Do not
take extra medicine to make up the missed dose.
Where can I get more information about ibuprofen and pseudoephedrine?
Your pharmacist has information about ibuprofen and pseudoephedrine written for health professionals that you may read.
What are the possible side effects of ibuprofen and pseudoephedrine?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication seek medical attention or call your doctor at once if you have
any of these serious side effects:
-
chest pain, weakness, shortness of breath, slurred speech, problems
with vision or balance;
-
black, bloody, or tarry stools, coughing up blood or vomit
that looks like coffee grounds;
-
fast, pounding, or uneven heartbeat;
-
severe dizziness, anxiety, restless feeling, or nervousness;
-
easy bruising or bleeding, unusual weakness, fever, chills,
body aches, flu symptoms;
-
increased blood pressure (severe headache, blurred vision,
trouble concentrating, chest pain, seizure);
-
urinating less than usual or not at all;
-
skin rash, severe tingling, numbness, pain, muscle
weakness; or
-
fever, headache, neck stiffness, chills, increased sensitivity
to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects may include:
-
upset stomach, nausea, heartburn, diarrhea, constipation;
-
bloating, gas, loss of appetite;
-
warmth, tingling, or redness under your skin;
-
dizziness, headache, feeling excited or restless;
-
sleep problems (insomnia);
-
skin itching or rash; or
-
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about ibuprofen and pseudoephedrine?
Always ask a doctor before giving a cough or cold medicine to a child.
Death can occur from the misuse of cough and cold medicines in very young children.
Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as
isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or
tranylcypromine (Parnate) within the past 14 days.
Ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart
attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called
coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as
chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including
bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without
warning at any time while you are taking ibuprofen.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This
includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not take more of this medication than is recommended. An overdose of ibuprofen can
cause damage to your stomach or intestines.
What should I avoid while taking ibuprofen and pseudoephedrine?
Do not use any other over-the-counter cough, cold, or pain medication without first asking
your doctor or pharmacist. Ibuprofen and pseudoephedrine are contained in many medicines available
over the counter. If you take certain products together you may accidentally take too much of either
medication. Read the label of any other medicine you are using to see if it contains ibuprofen or
pseudoephedrine.
Avoid drinking alcohol while taking ibuprofen and pseudoephedrine. If you drink more than
3 alcoholic beverages a day, ibuprofen may increase your risk of stomach bleeding.
What other drugs will affect ibuprofen and pseudoephedrine?
Before taking ibuprofen and pseudoephedrine, tell your doctor if you are taking any of the
following drugs:
-
a blood thinner such as warfarin (Coumadin);
-
steroids (prednisone and others);
-
diuretics (water pills), or medicines to treat high blood
pressure;
-
a beta-blocker such as atenolol (Tenormin), carteolol
(Cartrol), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), timolol
(Blocadren), and others;
-
antidepressants such as amitriptyline (Elavil), clomipramine
(Anafranil), imipramine (Janimine, Tofranil), and others; or
-
aspirin or other NSAIDs (non-steroidal anti-inflammatory
drugs) such as diclofenac (Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin,
ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic),
nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
This list is not complete and there may be other drugs that can interact with
ibuprofen and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of ibuprofen and pseudoephedrine?
