ADVIL SINUS CONGESTION AND PAIN (ibuprofen 200 mg phenylephrine hydrochloride 10 mg) Dailymed

Warnings Section

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• •hives
• •facial swelling
• •asthma (wheezing)
• •shock
• •skin reddening
• •rash
• •bulers

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• •are age 60 or older
• •have had stomach ulcers or bleeding problems
• •take a blood thinning (anticoagulant) or steroid drug
• •take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• •have 3 or more alcoholic drinks every day while using this product
• •take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

• •in children under 12 years of age because this product contains too much medication for children under this age
• •if you have ever had an allergic reaction to any other pain reliever/fever reducer
• •right before or after heart surgery
• •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if

• •stomach bleeding warning applies to you
• •you have problems or serious side effects from taking pain relievers or fever reducers
• •you have a history of stomach problems, such as heartburn
• •you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
• •you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• •under a doctor's care for any serious condition
• •taking any other product that contains phenylephrine or any other nasal decongestant
• •taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• •taking any other drug

When using this product

• •take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• •you experience any of the following signs of stomach bleeding:
  • ofeel faint
  • ovomit blood
  • ohave bloody or black stools
  • ohave stomach pain that does not get better
• •you have symptoms of heart problems or stroke:
  • ochest pain
  • otrouble breathing
  • oweakness in one part or side of body
  • oslurred speech
  • oleg swelling
• •pain gets worse or lasts more than 7 days
• •fever gets worse or lasts more than 3 days
• •nasal congestion lasts for more than 7 days
• •symptoms continue or get worse
• •redness or swelling is present in the painful area
• •you get nervous, dizzy, or sleepless
• •any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.