Label: NAPROXEN SODIUM tablet
- NDC Code(s): 37835-594-01, 37835-594-03
- Packager: Bi-Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 1, 2025
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT(in each caplet) Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
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PURPOSEPain reliever/fever reducer
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USES• temporarily relieves minor aches and pains due to: • minor pain of arthritis - • muscular aches - • backache - • menstrual cramps - • headache - • toothache ...
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WARNINGSAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives - • facial swelling - • asthma (wheezing ...
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DO NOT USE• if you have ever had an allergic reaction to any other pain reliever/fever reducer - • right before or after heart surgery
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ASK A DOCTOR BEFORE USE IF• the stomach bleeding warning applies to you - • you have a history of stomach problems, such as heartburn - • you have had high blood pressure, heart disease, liver cirrhosis, kidney ...
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE• under a doctor's care for any serious condition - • taking aspirin for heart attack or stroke, because naproxen may decrease this benifits of aspirin - • taking any other drug
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WHEN USING THIS PRODUCT• take with food or milk if stomach upset occurs
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STOP USE AND ASK 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 ...
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PREGNANCY/BREASTFEEDINGIf pregnant or breast-feeding,ask a 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 ...
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KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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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 ...
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OTHER INFORMATIONeach caplet contains:sodium 20 mg - store at 20 - 25°C (68 - 77°F). avoid high humidity and excessive heat above 40°C (104°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
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INACTIVE INGREDIENTSFD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
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QUESTIONS?call toll free - 1-844-912-4012
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SPL UNCLASSIFIED SECTIONDistributed by: BI-MART - Eugene, OR 97402
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PRINCIPAL DISPLAY PANEL-100 CountNDC 37835-594-01 - Compare to the active ingredients in ALEVE - ®** FAST LONG-LASTING PAIN RELIEF - NAPROXEN SODIUM - CAPLETS 220 MG - PAIN RELIEVER/FEVER REDUCER (NSAID) WITH 8 TO 12 HOUR DOSING - 100 ...
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PRINCIPAL DISPLAY PANEL-300 CountNDC 37835-594-03 - Compare to the active ingredients in ALEVE - ®** FAST LONG-LASTING PAIN RELIEF - NAPROXEN SODIUM - CAPLETS 220 MG - PAIN RELIEVER/FEVER REDUCER (NSAID) WITH 8 TO 12 HOUR DOSING - 300 ...
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INGREDIENTS AND APPEARANCEProduct Information