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)PurposesNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)nonsteroidal anti-inflammatory drugPain reliever/fever reducerPseudoephedrine HCl 120 mg, extended-releaseNasal decongestant
- Temporarily relieves these cold, sinus, and flu symptoms:sinus pressureminor body aches and painsheadachenasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)fever
- Naproxen sodium 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
- If 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.in children under 12 years of age
Ask A Doctor Before Use If
- The stomach bleeding warning applies to youyou 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 diureticyou have problems or serious side effects from taking pain relievers or fever reducers
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor's care for any serious conditiontaking 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 swellingredness or swelling is present in the painful areaany new symptoms appearfever gets worse or lasts more than 3 daysyou have difficulty swallowing or the caplet feels stuck in your throatyou get nervous, dizzy, or sleeplessnasal congestion lasts more than 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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 directedthe smallest effective dose should be usedswallow whole; do not crush or chewdrink a full glass of water with each doseadults and children 12 years and older1 caplet every 12 hoursdo not take more than 2 caplets in 24 hourschildren under 12 yearsdo not use
- Each caplet contains: sodium 21 mgmeets USP Dissolution Test 2store at 20-25°C (68-77°F)do not use if blister unit is torn or brokenstore in a dry place
Colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
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