Naproxen Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE STARCH, CORN TALC TITANIUM DIOXIDE I3
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel QUALITY + PLUS NDC 50844-271-43 † Compare to active ingredient in Aleve® Tablets NAPROXEN NAPROXEN SODIUM USP, 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) 60 Packets of 1 Tablet each 220 mg each ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF PACKET IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Tablets. 50844 ORG Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Quality Plus 44-746 Quality Plus 44-746
- Principal Display Panel QUALITY + PLUS NDC 50844-271-43 † Compare to active ingredient in Aleve® Tablets NAPROXEN NAPROXEN SODIUM USP, 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) 60 Packets of 1 Tablet each 220 mg each ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF PACKET IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Tablets. 50844 ORG Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Quality Plus 44-746 Quality Plus 44-746
Overview
Uses Temporarily relieves minor aches and pains due to minor pain of arthritis menstrual cramps backache toothache muscular aches headache the common cold Temporarily reduces fever.
Indications & Usage
Uses Temporarily relieves minor aches and pains due to minor pain of arthritis menstrual cramps backache toothache muscular aches headache the common cold Temporarily reduces fever.
Dosage & Administration
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and over: ■ Take 1 tablet every 8 to 12 hours while symptoms persist. ■ For the first dose you may take 2 tablets within the first hour. ■ Do not exceed 2 tablets in any 8 to 12 hour period. ■ Do not exceed 3 tablets in a 24 hour period. Children under 12 years: Ask a doctor.
Warnings & Precautions
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock skin reddening hives rash blisters facial swelling asthma (wheezing) If 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 older have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take 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 reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic you 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 condition taking 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 faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear 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. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Pain reliever/fever reducer
Do Not Use
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
When Using
When using this product take with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear
Keep Out of Reach of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information each tablet contains: sodium 20 mg store at room temperature 68°-77°F (20°-25°C) avoid high humidity and excessive heat above 104°F (40°C) tamper evident sealed packets do not use any open or torn packets
Questions
Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
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