OTC - QUESTIONS SECTION.
Questions or Comments 1-800-395-0689.
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DOSAGE & ADMINISTRATION SECTION.
Directions. Use up to 21 days unless directed by your doctor.Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.DailyPer DoseFor your arthritis pain: Use times per day every dayDo not use on more than body areas at the same timeUse ENCLOSED DOSING CARD to measure doseFor each upper body area (hand, wrist or elbow)-Squeeze out 2.25 inches (2 grams)For each lower body (foot, ankle or knee)-Squeeze out 4.5 inches (4 grams)Read the enclosed User Guide for complete instructions: use only as directeddo not use more than directed for longer than directedapply to only clean, dry skin that does not have cuts, open wounds, infections or rashesdo not apply in the same area as any other productdo not apply with external heat such as heating paddo not apply to bandage over the treated areastore ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards is re-usable.. Use times per day every day. Do not use on more than body areas at the same time. For each upper body area (hand, wrist or elbow)-Squeeze out 2.25 inches (2 grams). For each lower body (foot, ankle or knee)-Squeeze out 4.5 inches (4 grams). use only as directed. do not use more than directed for longer than directed. apply to only clean, dry skin that does not have cuts, open wounds, infections or rashes. do not apply in the same area as any other product. do not apply with external heat such as heating pad. do not apply to bandage over the treated area. store ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards is re-usable.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. CARBOMER HOMOPOLYER TYPE C, COCOYL CAPRYLOCAPRATE, FRAGRANCE, ISOPROPYL ALCOHOL; MINERAL OIL; POLYOXYL 20 CETOSTEARYL ETHER; PROPYLENE GLYCOL, PURIFIED WATER, STRONG AMONIA SOLUTION.
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INDICATIONS & USAGE SECTION.
Uses. for temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas) this product may take up to days to work for arthritis pain; it is not for immediate relief. If no pain relief in days, stop use.. for temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas) hand, wrist, elbow (upper body areas). foot, ankle, knee (lower body areas). this product may take up to days to work for arthritis pain; it is not for immediate relief. If no pain relief in days, stop use.
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OTHER SAFETY INFORMATION.
Other information. store at 20-25C (68-77F). Keep from freezing.read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.. store at 20-25C (68-77F). Keep from freezing.. read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredient Diclofenac sodium (NSAID) 1% (equivalent to 0.93% diclofenac) nonsteroidal anti-inflammatory drug.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if. you have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou are under age 18 years. It is not known if this drug works or is safe in children under 18 years.. you have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you are under age 18 years. It is not known if this drug works or is safe in children under 18 years.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use. under doctors care for any serious conditiontaking any other drug. under doctors care for any serious condition. taking any other drug.
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OTC - DO NOT USE SECTION.
Do not use. if you have ever had an allergic reaction to any other pain reliever or to fever reducerfor strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgeryon more than body areas at the same timein the eyes, nose or mouth. if you have ever had an allergic reaction to any other pain reliever or to fever reducer. for strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery. on more than body areas at the same time. in the eyes, nose or mouth.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. If swallowed, 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 this product 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.
Arthritis pain reliever.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. pain gets worse or lasts more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of serious condition.you experience any of the following signs of stomach bleeding: feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better you have symptoms of heart problems or stroke: chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech pain gets worse or lasts more than 21 days. redness or swelling is present in the painful area. fever occurs. skin irritation occurs. any new symptoms appear. These could be signs of serious condition.. you experience any of the following signs of stomach bleeding: feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better feel faint. have bloody or black stools. vomit blood. have stomach pain that does not get better. you have symptoms of heart problems or stroke: chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech chest pain. trouble breathing. leg swelling. weakness in one part or side of body. slurred speech.
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OTC - WHEN USING SECTION.
When using this product. avoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water. avoid contact with eyes, nose, or mouth. if eye contact occurs, rinse thoroughly with water.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
NEWDIFFERENT INGREDIENTDICLOFENACSODIUMALEVE(R) ARTHRITIS PAIN GELDiclofenac Sodium Topical Gel 1% (NSAID) Arthritis Pain RelieverFOR DAILYTREATMENT OFARTHRITIS PAINANTI-INFLAMMATORYFOR EXTERNAL USE ONLYNET WT 3.53 OZ (100 g). Carton label AleveX Pain Gel.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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WARNINGS SECTION.
For external use only. Allergy alert: Diclofenac may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesasthma (wheezing)skin reddeningblistersfacial swellingshockrashIf an allergic reaction occurs, stop use and seek medical help right away.. hives. asthma (wheezing). skin reddening. blisters. facial swelling. shock. rash. Liver Warning: This product contains diclofenac. Liver damage may occur if you apply more or for longer time than directedwhen using other drugs containing diclofenac. more or for longer time than directed. when using other drugs containing diclofenac. 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 blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this productapply more or for longer than directed. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. apply more or for longer 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 or to fever reducerfor strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgeryon more than body areas at the same timein the eyes, nose or mouth. if you have ever had an allergic reaction to any other pain reliever or to fever reducer. for strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery. on more than body areas at the same time. in the eyes, nose or mouth. Ask doctor before use if. you have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou are under age 18 years. It is not known if this drug works or is safe in children under 18 years.. you have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you are under age 18 years. It is not known if this drug works or is safe in children under 18 years.. Ask doctor or pharmacist before use. under doctors care for any serious conditiontaking any other drug. under doctors care for any serious condition. taking any other drug. When using this product. avoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water. avoid contact with eyes, nose, or mouth. if eye contact occurs, rinse thoroughly with water. Stop use and ask doctor if. pain gets worse or lasts more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of serious condition.you experience any of the following signs of stomach bleeding: feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better you have symptoms of heart problems or stroke: chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech pain gets worse or lasts more than 21 days. redness or swelling is present in the painful area. fever occurs. skin irritation occurs. any new symptoms appear. These could be signs of serious condition.. you experience any of the following signs of stomach bleeding: feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better feel faint. have bloody or black stools. vomit blood. have stomach pain that does not get better. you have symptoms of heart problems or stroke: chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech chest pain. trouble breathing. leg swelling. weakness in one part or side of body. slurred speech. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use this product 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. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).
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