Ibuprofen (eye-bue-PROE-fen), Pseudoephedrine Hydrochloride (soo-doe-e-FED-rin hye-droe-KLOR-ide)

Relieves symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose. This medicine contains an NSAID.

Brand Name(s):

Advil Cold & Sinus, Cold & Sinus Relief, Good Neighbor Pharmacy Ibuprofen Cold & Sinus, Ibuprofen Cold & Sinus, Leader Cold & Sinus, Leader Cold & Sinus Relief, TopCare Ibuprofen Cold & Sinus

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Filled Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 2 weeks.
• Some medicines can affect how ibuprofen/pseudoephedrine works. Tell your doctor if you are using any of the following:
  • Blood thinner
  • Diuretic (water pill)
  • Other cold medicine
  • Other NSAIDs (including aspirin, diclofenac, naproxen)
  • Steroid medicine
• Do not drink 3 or more alcoholic drinks while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of your pregnancy, unless your doctor tells you to.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, heart disease, high blood pressure, asthma, diabetes, thyroid problems, trouble urinating, or a history of stomach problems (including heartburn) or stroke.
• This medicine may cause the following problems:
  • Increased risk of heart attack, heart failure, or stroke
  • Stomach bleeding
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread, coughing up blood, nausea, unusual sweating, fainting
• Numbness or weakness on one side of your body, pain in your lower leg
• Severe constipation, stomach pain, vomiting of blood, bloody or black, tarry stools
• Sudden or severe headache, problems with vision, speech, or walking
• Swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin

If you notice these less serious side effects, talk with your doctor:

• Dizziness, nervousness, trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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