Label: NAPROXEN- naproxen sodium tablet
- NDC Code(s): 68788-7572-2, 68788-7572-3, 68788-7572-4, 68788-7572-6
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-954
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
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
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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, kidney disease, asthma, or had a stroke
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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
- Ask a doctor or pharmacist before use if
- When using this product
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Stop use and ask 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 a stomach pain that dose not get better
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- 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 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
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
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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
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- 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
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- children under 12 years: ask a doctor
- Storage
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7572(NDC:57896-954) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;417 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7572-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 2 NDC:68788-7572-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 3 NDC:68788-7572-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 4 NDC:68788-7572-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 01/01/2019 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-7572)
