Description
Ibuprofen and pseudoephedrine combination is used to relieve symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.
This medicine is available as an over-the-counter (OTC) product.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ibuprofen and pseudoephedrine combination in children 12 years of age and older. This medicine should not be used in children younger than 12 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibuprofen and pseudoephedrine combination in the elderly. However, elderly patients more likely to develop age-related stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
Substance Name
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Substance Name
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dihydroergotamine
- Furazolidone
- Iproniazid
- Isocarboxazid
- Ketorolac
- Linezolid
- Methylene Blue
- Moclobemide
- Nialamide
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Selegiline
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amtolmetin Guacil
- Anagrelide
- Apixaban
- Ardeparin
- Argatroban
- Asciminib
- Aspirin
- Balsalazide
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betrixaban
- Bismuth Subsalicylate
- Bivalirudin
- Bromfenac
- Budesonide
- Bufexamac
- Bumetanide
- Cangrelor
- Carbamazepine
- Celecoxib
- Certoparin
- Chlorothiazide
- Chlorthalidone
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cilostazol
- Citalopram
- Clomipramine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Amikacin
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
- Timolol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Tobacco
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to aspirin or
- Asthma or
- Diabetes or
- Heart attack, history of or
- Heart disease or
- High blood pressure, history of or
- Kidney disease or
- Liver disease (eg, cirrhosis) or
- Stomach ulcers or bleeding, history of or
- Stroke, history of or
- Thyroid problems or
- Trouble urinating caused by enlarged prostate—Use with caution. May make these conditions worse.
- Heart surgery—Should not be used to relieve pain right before or after the surgery.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Follow the instructions on the medicine label if you are using this medicine without a prescription.
You may take this medicine with milk or food to avoid stomach upset.
Do not drink 3 or more alcoholic drinks while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For symptoms of cold or flu:
- For oral dosage form (liquid-filled capsules):
- Adults and children 12 years of age and older—1 to 2 capsules every 4 to 6 hours a day. Do not take more than 6 capsules per day. Each capsule contains 200 milligrams (mg) ibuprofen and 30 mg pseudoephedrine.
- Children younger than 12 years of age—Use is not recommended.
- For oral dosage form (tablets):
- Adults and children 12 years of age and older—1 to 2 tablets every 4 to 6 hours a day. Do not take more than 6 tablets per day. Each tablet contains 200 milligrams (mg) ibuprofen and 30 mg pseudoephedrine.
- Children younger than 12 years of age—Use is not recommended.
- For oral dosage form (liquid-filled capsules):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not take ibuprofen and pseudoephedrine combination with or within 2 weeks of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop extremely high blood pressure.
This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (eg, NSAIDs, steroid, blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.
This medicine may increase your risk of having a heart attack, heart failure, or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain or tightness, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bloody or black, tarry stools
- chest pain or tightness
- confusion
- constipation
- cough
- decrease urine output
- diarrhea
- difficulty in speaking
- difficulty swallowing
- dilated neck veins
- dizziness
- double vision
- fast heartbeat
- headache
- heartburn
- hives, itching, skin rash
- inability to speak
- inability to move the arms, legs, or facial muscles
- indigestion
- irregular breathing
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe stomach pain, cramping, or burning
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Dizziness
- nervousness
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
