DOSAGE & ADMINISTRATION SECTION.
Directions odo not take more than directedothe smallest effective dose should be usedodrink full glass of water with each doseoAdults and children 12 years and older: otake tablet every to 12 hours while symptoms lastofor the first dose you may take tablets within the first hour odo not exceed tablets in any 8- to 12-hour period odo not exceed tablets in 24-hour periodChildren under 12 years:ask doctor. odo not take more than directed. othe smallest effective dose should be used. odrink full glass of water with each dose. oAdults and children 12 years and older: otake tablet every to 12 hours while symptoms last. ofor the first dose you may take tablets within the first hour odo not exceed tablets in any 8- to 12-hour period odo not exceed tablets in 24-hour period.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients FD&C blue no. aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. otemporarily relieves minor aches and pains due to:obackacheomuscular achesominor pain of arthritisomenstrual crampsoheadacheotoothacheothe common coldotemporarily reduces fever. otemporarily relieves minor aches and pains due to:. obackache. omuscular aches. ominor pain of arthritis. omenstrual cramps. oheadache. otoothache. othe common cold. otemporarily reduces fever.
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OTHER SAFETY INFORMATION.
Other information oeach tablet contains: sodium 21 mgostore at 20-25C (68-77F). Avoid high humidity and excessive heat above 40C (104F).. oeach tablet contains: sodium 21 mg. ostore at 20-25C (68-77F). Avoid high humidity and excessive heat above 40C (104F).
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet) Naproxen sodium 220 mg(naproxen 200 mg) (NSAID)nonsteroidal 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, 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, 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 any other drug. ounder doctors care for any serious condition. 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 reduceroright before or after heart surgery. oif you have ever had an allergic reaction to any other pain reliever/fever reducer. oright before or after heart surgery.
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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 during the last months of 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 reducer.
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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 swellingopain gets worse or lasts more than 10 daysofever gets worse or lasts more than daysoyou have difficulty swallowingoit feels like the pill is stuck in your throatoredness or swelling is present in the painful areaoany new symptoms appear. 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. opain gets worse or lasts more than 10 days. ofever gets worse or lasts more than days. oyou have difficulty swallowing. oit feels like the pill is stuck in your throat. oredness or swelling is present in the painful area. oany new symptoms appear.
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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 Compare to Aleve(R) Back Muscle Pain active ingredientStrength to last 12 hoursnaproxen sodium tablets 220 mgPain Reliever/Fever Reducer (NSAID)BACK MUSCLE PAINFor temporary relief of minor back and muscle aches and painsactual size24 TABLETSKEEP CARTON FOR REFERENCE. 33d-an-naproxen-sodium.jpg.
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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.
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