OTC - DO NOT USE SECTION.
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 Parkinsons 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
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 during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Compare to Advil Sinus Congestion & Pain active ingredients Wal-Profen SINUS CONGESTION & PAIN IBUPROFEN 200 mg / PAIN RELIEVER / FEVER REDUCER (NSAID) PHENYLEPHRINE HYDROCHLORIDE 10 mg / NASAL DECONGESTANT, TABLETS NON-DROWSY Relief of: Nasal Congestion, Headache, Sinus Pressure, Fever, Nasal Swelling, Body Aches ACTUAL SIZE 10 COATED TABLETS SEE NEW WARNINGS ONE TABLET DOSE!
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug
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 (1-800-222-1222).
INDICATIONS & USAGE SECTION.
Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose
DOSAGE & ADMINISTRATION SECTION.
Directions do not take more than directed adults and children 12 years of age and over: take 1 tablet every 4 hours while symptoms persist. do not use more than 6 tablets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use because this product contains too much medication for children under this age
INACTIVE INGREDIENT SECTION.
Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
OTC - STOP USE SECTION.
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 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 - WHEN USING SECTION.
When using this product take with food or milk if stomach upset occurs
OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask a doctor or pharmacist before use if you are under a doctors 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
OTC - ASK DOCTOR SECTION.
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
STORAGE AND HANDLING SECTION.
Other information store at 20-25C (68-77). Avoid excessive heat above 40C (104F). read all warnings and directions before use. Keep carton.
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-719-9260
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.
OTC - PURPOSE SECTION.
Purposes Pain reliever/fever reducer Nasal decongestant