Chlorpheniramine, ibuprofen, and pseudoephedrine

Chlorpheniramine is an antihistamine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a decongestant.

Chlorpheniramine, ibuprofen, and pseudoephedrine is a combination medicine used to treat sneezing, itching, watery eyes, runny nose, stuffy nose, sinus congestion, headache, and pain or fever caused by allergies or the common cold.

Chlorpheniramine, ibuprofen, and pseudoephedrine may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Cold or cough medicine is only for short-term use until your symptoms get better.

Always follow the directions on the medicine label when giving cough or cold medicine to a child. Do not use the medicine just to make a child sleepy. Death can occur from misusing cough or cold medicines in very young children.

Carefully follow the dosing instructions based on your child's age and weight. Ask a doctor or pharmacist if you have questions.

Take this medicine with food or milk if it makes your stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not take this medicine for longer than 10 days without your doctor's advice.

If you need to have any type of surgery, tell the surgeon in advance if you have taken this medicine in the past few days.

Call your doctor if you have any new symptoms, or if you have a fever lasting longer than 3 days, a stuffy nose lasting longer than 7 days, or any redness or swelling.

Chlorpheniramine can affect the results of allergy skin tests. Inform any doctor who treats you that you are using this medicine.

Store this medicine at room temperature, away from moisture and heat.

Ibuprofen can raise your risk of a serious heart attack or stroke. Do not take this medicine right before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen can also lead to bleeding in the stomach or intestines, which can be life-threatening.

Do not take this medicine if you have used an MAO inhibitor in the last 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ibuprofen can raise your chances of having a fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine right before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also lead to stomach or intestinal bleeding, which can be life-threatening. These issues can happen unexpectedly while you are taking this medicine, especially in older adults.

You should not use this medicine if you are allergic to chlorpheniramine, ibuprofen, or pseudoephedrine, or if you have ever experienced an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use this medicine if you have taken an MAO inhibitor in the last 14 days. A dangerous interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if this medicine is safe for you if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• a breathing problem, such as asthma, emphysema, or bronchitis;
• liver or kidney disease;
• a thyroid disorder;
• glaucoma;
• diabetes;
• enlarged prostate or problems with urination; or
• fluid retention.

If you are pregnant, you should not take this medicine unless your doctor advises you to. Taking an NSAID during the last 20 weeks of pregnancy can lead to serious heart or kidney issues in the unborn baby and potential complications with your pregnancy.

Ask a doctor before using this medicine if you are breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you notice signs of a heart attack or stroke: chest pain that spreads to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• severe dizziness, trouble sleeping, or nervousness;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• severe headache, blurred vision, pounding in your neck or ears;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of chlorpheniramine, ibuprofen, and pseudoephedrine may include:

• upset stomach, mild heartburn, nausea, vomiting;
• bloating, gas, diarrhea, constipation;
• dizziness, headache, nervousness;
• flushing (warmth, redness, or tingly feeling);
• mild 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.

Usual Pediatric Dose for Allergic Rhinitis:

Chlorpheniramine/ibuprofen/pseudoephedrine 1 mg-100 mg-15 mg/5 mL oral suspension:6 yrs to 11 yrs: 10 mL orally every 6 hours not to exceed 4 doses daily.

Usual Pediatric Dose for Cold Symptoms:

Chlorpheniramine/ibuprofen/pseudoephedrine 1 mg-100 mg-15 mg/5 mL oral suspension:6 yrs to 11 yrs: 10 mL orally every 6 hours not to exceed 4 doses daily.

Since chlorpheniramine, ibuprofen, and pseudoephedrine is taken as needed, you might not have a regular dosing schedule. If you miss a dose and it’s nearly time for your next dose, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

• Avoid drinking alcohol. It may increase your risk of stomach bleeding.

• Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Ask your doctor before using ibuprofen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using chlorpheniramine, ibuprofen, and pseudoephedrine with any other medications, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect chlorpheniramine, ibuprofen, and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.