chlorpheniramine maleate, ibuprofen, phenylephrine HCl

FDA Drug Profile — Advil Multi-Symptom Cold and Flu

Drug Details

Generic Name
chlorpheniramine maleate, ibuprofen, phenylephrine HCl
Brand Names
Advil Multi-Symptom Cold and Flu
Application Number
NDA022113
Sponsor
Haleon US Holdings LLC
NDC Codes
2
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever minor body aches and pains nasal congestion runny nose sinus pressure sneezing reduces swelling of the nasal passages temporarily restores freer breathing through the nose

Warnings

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 blisters 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 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 you have a breathing problem such as emphysema or chronic bronchitis 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, glaucoma, 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 sedatives or tranquilizers taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine 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 avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness may cause excitability especially in children Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg 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 redness or swelling is present in the painful area you get nervous, dizzy, or sleepless symptoms continue or get worse any new symptoms appear 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.