![NAPROXEN SODIUM TABLET [PROFICIENT RX LP]](https://medic.hrt.org//dailymed/images/e668c80f-dd53-4b82-8678-5e4fccb13023/cdb60f74-ce23-4015-90eb-b23a2275f6cb-01.jpg)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- blisters
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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- the stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have asthma
Ask a doctor or pharmacist before use if you are
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- under a doctor’s care for any serious condition
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- taking any other drug
When using this product
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- take with food or milk if stomach upset occurs
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- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- you have difficulty swallowing
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- it feels like the pill is stuck in your throat
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- drink a full glass of water with each dose
Adults and children 12 years and older:
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- take 1 tablet every 8 to 12 hours while symptoms last
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- for the first dose you may take 2 tablets within the first hour
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- do not exceed 2 tablets in any 8- to 12-hour period
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- do not exceed 3 tablets in a 24-hour period
Children under 12 years:
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- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-596(NDC:45802-490) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue) Score no score Shape ROUND Size 10mm Flavor Imprint Code L490 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-596-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 2 NDC:63187-596-28 28 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 3 NDC:63187-596-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2015 4 NDC:63187-596-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2015 5 NDC:63187-596-90 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074661 04/11/2014 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-596) , RELABEL(63187-596)
