DOSAGE & ADMINISTRATION SECTION.
Directions. odo not take more than directedothe smallest effective dose should be usedoswallow whole; do not crush or chewodrink full glass of water with each doseoadults and children 12 years and older: caplet every 12 hours; do not take more than caplets in 24 hoursochildren under 12 years: do not use. odo not take more than directed. othe smallest effective dose should be used. oswallow whole; do not crush or chew. odrink full glass of water with each dose. oadults and children 12 years and older: caplet every 12 hours; do not take more than caplets in 24 hours. ochildren under 12 years: do not use.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these cold, sinus, and flu symptoms:osinus pressureominor body aches and painsoheadacheonasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)ofever. osinus pressure. ominor body aches and pains. oheadache. onasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose). ofever.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each caplet). Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)Pseudoephedrine HCl 120 mg, extended-releasenonsteroidal anti-inflammatory drug.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if. othe stomach bleeding warning applies to youoyou have history of stomach problems, such as heartburnoyou 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 strokeoyou are taking diureticoyou have problems or serious side effects from taking pain relievers or fever reducers. othe stomach bleeding warning applies to you. oyou have history of stomach problems, such as heartburn. oyou 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 stroke. oyou are taking diuretic. oyou have problems or serious side effects from taking pain relievers or fever reducers.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are. ounder doctors care for any serious conditionotaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirinotaking any other drug. ounder doctors care for any serious condition. otaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin. otaking any other drug.
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OTC - DO NOT USE SECTION.
Do not use. oif you have ever had an allergic reaction to any other pain reliever/fever reducer oright before or after heart surgeryoif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.oin children under 12 years of age. oif you have ever had an allergic reaction to any other pain reliever/fever reducer oright before or after heart surgery. oif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.. oin children under 12 years of age.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding,. ask health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.
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OTC - PURPOSE SECTION.
Purposes. Pain reliever/fever reducerNasal decongestant.
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OTC - QUESTIONS SECTION.
Questions or comments. 1-800-719-9260.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swellingoredness or swelling is present in the painful areaoany new symptoms appearofever gets worse or lasts more than daysoyou have difficulty swallowing or the caplet feels stuck in your throatoyou get nervous, dizzy, or sleeplessonasal congestion lasts more than days. oyou experience any of the following signs of stomach bleeding:. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:. ochest pain. otrouble breathing. oweakness in one part or side of body. oslurred speech. oleg swelling. oredness or swelling is present in the painful area. oany new symptoms appear. ofever gets worse or lasts more than days. oyou have difficulty swallowing or the caplet feels stuck in your throat. oyou get nervous, dizzy, or sleepless. onasal congestion lasts more than days.
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OTC - WHEN USING SECTION.
When using this product. otake with food or milk if stomach upset occurs. otake with food or milk if stomach upset occurs.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Package/Label Principal Display Panel. WalgreensWALGREENS oPHARMACIST RECOMMENDEDoCompare to the active ingredients in Aleve-D(R) Sinus ColdNON-DROWSYAll Day Sinus Cold DNAPROXEN SODIUM 220 mg PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg EXTENDED-RELEASE TABLETPAIN RELIEVER FEVER REDUCER (NSAID) NASAL DECONGESTANT12 Houro 12-hour multi-symptom relief of sinus pressure, headache, sinus congestion, nasal congestion body acheso caplet 12 hours20 CAPLETS(capsule-shaped tablets)ACTUAL SIZE. all-day-sinus-&-cold-d-front. all-day-sinus-&-cold-d-back.
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STORAGE AND HANDLING SECTION.
Other information. oeach caplet contains: sodium 21 mgoFDA approved dissolution specification differs from the USP dissolution specificationostore at 20-25C (68-77F)ostore in dry place. oeach caplet contains: sodium 21 mg. oFDA approved dissolution specification differs from the USP dissolution specification. ostore at 20-25C (68-77F). ostore in dry place.
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WARNINGS SECTION.
Warnings. Allergy alert: Naproxen sodium may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:ohivesofacial swellingoasthma (wheezing)oshockoskin reddeningorashoblistersIf 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:oare age 60 or olderohave had stomach ulcers or bleeding problemsotake blood thinning (anticoagulant) or steroid drugotake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)ohave or more alcoholic drinks every day while using this productotake more or for longer time than directedHeart 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.. ohives. ofacial swelling. oasthma (wheezing). oshock. oskin reddening. orash. oblisters. oare age 60 or older. ohave had stomach ulcers or bleeding problems. otake blood thinning (anticoagulant) or steroid drug. otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). ohave or more alcoholic drinks every day while using this product. otake more or for longer time than directed. Do not use. oif you have ever had an allergic reaction to any other pain reliever/fever reducer oright before or after heart surgeryoif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.oin children under 12 years of age. oif you have ever had an allergic reaction to any other pain reliever/fever reducer oright before or after heart surgery. oif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.. oin children under 12 years of age. Ask doctor before use if. othe stomach bleeding warning applies to youoyou have history of stomach problems, such as heartburnoyou 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 strokeoyou are taking diureticoyou have problems or serious side effects from taking pain relievers or fever reducers. othe stomach bleeding warning applies to you. oyou have history of stomach problems, such as heartburn. oyou 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 stroke. oyou are taking diuretic. oyou have problems or serious side effects from taking pain relievers or fever reducers. Ask doctor or pharmacist before use if you are. ounder doctors care for any serious conditionotaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirinotaking any other drug. ounder doctors care for any serious condition. otaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin. otaking any other drug. When using this product. otake with food or milk if stomach upset occurs. otake with food or milk if stomach upset occurs. Stop use and ask doctor if. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swellingoredness or swelling is present in the painful areaoany new symptoms appearofever gets worse or lasts more than daysoyou have difficulty swallowing or the caplet feels stuck in your throatoyou get nervous, dizzy, or sleeplessonasal congestion lasts more than days. oyou experience any of the following signs of stomach bleeding:. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:. ochest pain. otrouble breathing. oweakness in one part or side of body. oslurred speech. oleg swelling. oredness or swelling is present in the painful area. oany new symptoms appear. ofever gets worse or lasts more than days. oyou have difficulty swallowing or the caplet feels stuck in your throat. oyou get nervous, dizzy, or sleepless. onasal congestion lasts more than days. If pregnant or breast-feeding,. ask health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by 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 Poison Control Center right away (1-800-222-1222).
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