Drug Facts

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Antihistamine

Pain reliever/Fever reducer

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

•temporarily relieves these symptoms associated with the common cold or flu:oheadacheofeverominor body aches and painsonasal congestionorunny noseosinus pressureosneezing
•reduces swelling of the nasal passages
•temporarily restores freer breathing through the nose

WARNINGS SECTION

Warnings

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

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

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

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:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get better
•you have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg 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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

•do not take more than directed
•adults and children 12 years of age and over: otake 1 tablet every 4 hours while symptoms persistodo not take more than 6 tablets in any 24-hour period, unless directed by a doctor
•children under 12 years of age: do not use

STORAGE AND HANDLING SECTION

Other information

•read all warnings and directions before use. Keep carton.
•store at 20-25°C (68-77°F)
•avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Additional Information

READ AND KEEP CARTON FOR COMPLETEWARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.Do Not Use if plastic blister or foil barrier is broken.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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