The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each caplet)PurposesIbuprofen 200 mg (NSAID)nonsteroidal anti-inflammatory drugPain reliever/fever reducerPhenylephrine HCl 10 mgNasal decongestant
- Temporarily relieves these symptoms associated with the common cold or flu:headachefeversinus pressurenasal congestionminor body aches and painsreduces swelling of the nasal passagestemporarily restores freer breathing through the nose
- Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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 ageif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgeryif 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 youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou 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 strokeyou are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor's care for any serious conditiontaking any other product that contains phenylephrine or any other nasal decongestanttaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking 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:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysnasal congestion lasts for more than 7 dayssymptoms continue or get worseredness or swelling is present in the painful areayou get nervous, dizzy, or sleeplessany new symptoms appear
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
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)
- Do not take more than directedadults and children 12 years of age and over:take 1 caplet every 4 hours while symptoms persistdo not use more than 6 caplets in any 24-hour period unless directed by a doctorchildren under 12 years of age: do not use because this product contains too much medication for children under this age
- Store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).read all warnings and directions before use. Keep carton.do not use if blister unit is torn or broken
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide
* Please review the disclaimer below.