Naproxen Sodium

Tablet, Film Coated · Oral

Over the counter Nonsteroidal Anti-inflammatory Drug 5 recalls

Boxed warning. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ( 5.1 )]. Naproxen Sodium Controlled-Release Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.…

Uses

Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [ see Warnings and Precautions ( 5 ) ]. Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )

Dosage and administration

Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ) RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily. Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiring greater analgesic benefit, two 750 mg tablets or three 500 mg tablets may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets For the treatment of Acute Gout: The dosage is two to three 500 mg tablets once daily on the first day, followed by two 500 mg tablets once daily, until the attack has subsided. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of Naproxen Sodium Controlled-Release Tablets and other treatment options before deciding to use Naproxen Sodium Controlled-Release Tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with Naproxen Sodium Controlled-Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. 2.2 Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis The recommended starting dose of Naproxen Sodium Controlled-Release Tablets in adults is two Naproxen Sodium Controlled-Release 375 mg tablets (750 mg) once daily, one Naproxen Sodium Controlled-Release 750 mg (750 mg) once daily, or two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with Naproxen Sodium Controlled-Release Tablets as a single daily dose. During long-term administration, the dose of Naproxen Sodium Controlled-Release Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of Naproxen Sodium Controlled-Release Tablets well, the dose may be increased to two Naproxen Sodium Controlled-Release 750 mg tablets (1,500 mg), or three Naproxen Sodium Controlled-Release 500 mg tablets (1,500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk [ see Clinical Pharmacology ( 12.3 ) ]. The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit. 2.3 Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis The recommended starting dose is two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg) once daily. For patients requiring greater analgesic benefit, two Naproxen Sodium Controlled-Release 750 mg tablets (1,500 mg) or three Naproxen Sodium Controlled-Release 500 mg tablets (1,500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg). 2.4 Acute Gout The recommended dose on the first day is two to three Naproxen Sodium Controlled-Release 500 mg tablets (1,000 to 1,500 mg) once daily, followed by two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg) once daily, until the attack has subsided. 2.5 Dosage Adjustments in Patients with Hepatic Impairment A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients [ see Warnings and Precautions ( 5.3 ) ]. Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of Naproxen Sodium Controlled-Release Tablets and other treatment options before deciding to use Naproxen Sodium Controlled-Release Tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with Naproxen Sodium Controlled-Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. 2.2 Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis The recommended starting dose of Naproxen Sodium Controlled-Release Tablets in adults is two Naproxen Sodium Controlled-Release 375 mg tablets (750 mg) once daily, one Naproxen Sodium Controlled-Release 750 mg (750 mg) once daily, or two Naproxen Sodium Controlled-Release 500 mg tablets (1,000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with Naproxen Sodium Controlled-Release Tablets as a single daily dose. During long-term administration, the dose of Naproxen Sodium Controlled-Release Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of Naproxen Sodium Controlled-Release Tablets well, the dose may be increased to two Naproxen Sodium Controlled-Release 750 mg tablets (1,500 mg), or three Naproxen Sodium Controlled-Release 500 mg tablets (1,500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required.

Label text from the FDA structured product label by Upsher-Smith Laboratories, LLC (revised Dec 1, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Naproxen Sodium NDC products (153)

NDCStrength & formLabelerType
50090-5238Naproxen Sodium 550 mg/1
Tablet, Film Coated		A-S Medication SolutionsANDA
50090-0685Naproxen Sodium 220 mg/1
Tablet, Film Coated		A-S Medication SolutionsANDA
57344-145Naproxen Sodium 220 mg/1
Tablet, Coated		AAA Pharmaceutical, Inc.ANDA
55301-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		AAFES/Your Military ExchangesANDA
80425-0574Naproxen Sodium 550 mg/1
Tablet		Advanced Rx of Tennessee, LLCANDA
80425-0532Naproxen Sodium 550 mg/1
Tablet		Advanced Rx of Tennessee, LLCANDA
80425-0531Naproxen Sodium 550 mg/1
Tablet		Advanced Rx of Tennessee, LLCANDA
72288-988Naproxen Sodium 220 mg/1
Tablet, Film Coated		Amazon.com Services LLCANDA
61504-145Naproxen Sodium 220 mg/1
Tablet, Coated		AMERIFOODS TRADING COMPANYANDA
76420-637Naproxen Sodium 275 mg/1
Tablet		Asclemed USA, Inc.ANDA
76420-627Naproxen Sodium 550 mg/1
Tablet		Asclemed USA, Inc.ANDA
53185-604Naproxen Sodium 220 mg/1
Tablet, Film Coated		Athlete's Needs IncANDA
65862-515Naproxen Sodium 275 mg/1
Tablet, Film Coated		Aurobindo Pharma LimitedANDA
65862-516Naproxen Sodium 550 mg/1
Tablet, Film Coated		Aurobindo Pharma LimitedANDA
58602-738Naproxen Sodium 220 mg/1
Tablet, Film Coated		Aurohealth LLCANDA
58602-819Naproxen Sodium 220 mg/1
Tablet, Film Coated		Aurohealth LLCANDA
58602-845Naproxen Sodium 220 mg/1
Tablet, Film Coated		Aurohealth LLCANDA
21130-690Naproxen Sodium 220 mg/1
Tablet		BETTER LIVING BRANDS LLC.ANDA
21130-856Naproxen Sodium 220 mg/1
Tablet, Film Coated		Better Living Brands, LLCANDA
37835-594Naproxen Sodium 220 mg/1
Tablet		Bi-MartANDA
71335-3075Naproxen Sodium 550 mg/1
Tablet		Bryant Ranch PrepackANDA
71335-2294Naproxen Sodium 550 mg/1
Tablet		Bryant Ranch PrepackANDA
71335-1925Naproxen Sodium 275 mg/1
Tablet, Film Coated		Bryant Ranch PrepackANDA
71335-9663Naproxen Sodium 550 mg/1
Tablet		Bryant Ranch PrepackANDA
71335-1650Naproxen Sodium 550 mg/1
Tablet, Film Coated		Bryant Ranch PrepackANDA
71335-1061Naproxen Sodium 220 mg/1
Tablet, Film Coated		Bryant Ranch PrepackANDA
63629-8516Naproxen Sodium 550 mg/1
Tablet		Bryant Ranch PrepackANDA
63629-8517Naproxen Sodium 550 mg/1
Tablet		Bryant Ranch PrepackANDA
71335-0822Naproxen Sodium 550 mg/1
Tablet, Film Coated		Bryant Ranch PrepackANDA
69230-329Naproxen Sodium 220 mg/1
Tablet, Film Coated		Camber Consumer Care IncANDA
41520-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Care One (American Sales Company)ANDA
72476-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Care One (Retail Business Services, LLC.)ANDA
63868-466Naproxen Sodium 220 mg/1
Tablet, Coated		Chain Drug Marketing AssociationANDA
63868-465Naproxen Sodium 220 mg/1
Tablet, Coated		Chain Drug Marketing AssociationANDA
83324-108Naproxen Sodium 220 mg/1
Tablet, Coated		CHAIN DRUG MARKETING ASSOCIATION, INC.ANDA
83324-109Naproxen Sodium 220 mg/1
Tablet, Coated		CHAIN DRUG MARKETING ASSOCIATION, INC.ANDA
51316-762Naproxen Sodium 220 mg/1
Tablet		CVSANDA
51316-761Naproxen Sodium 220 mg/1
Tablet		CVSANDA
59779-914Naproxen Sodium 220 mg/1
Tablet, Film Coated		CVS PharmacyANDA
69842-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		CVS PharmacyANDA
69842-811Naproxen Sodium 220 mg/1
Tablet, Film Coated		CVS PharmacyANDA
51316-608Naproxen Sodium 220 mg/1
Tablet		CVS Pharmacy, Inc.ANDA
72189-332Naproxen Sodium 550 mg/1
Tablet		Direct RxANDA
55910-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDA
43598-058Naproxen Sodium 220 mg/1
Tablet, Coated		Dr Reddy's Laboratories IncANDA
43598-494Naproxen Sodium 275 mg/1
Tablet, Film Coated		Dr. Reddy's Laboratories Inc.ANDA
43598-495Naproxen Sodium 550 mg/1
Tablet, Film Coated		Dr. Reddy's Laboratories Inc.ANDA
43598-073Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
43598-074Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
43598-072Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
43598-071Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
43598-059Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
43598-060Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories IncANDA
55111-273Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories LimitedANDA
55111-272Naproxen Sodium 220 mg/1
Tablet, Coated		Dr.Reddy's Laboratories LimitedANDA
49035-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDA
81522-045Naproxen Sodium 220 mg/1
Tablet, Coated		FSA STORE INC.ANDA
68462-179Naproxen Sodium 550 mg/1
Tablet		Glenmark Pharmaceuticals Inc., USAANDA
68462-178Naproxen Sodium 275 mg/1
Tablet		Glenmark Pharmaceuticals Inc., USAANDA
62207-327Naproxen Sodium 220 mg/1
Tablet		Granules India LtdANDA
62207-328Naproxen Sodium 220 mg/1
Tablet		Granules India LtdANDA
62207-728Naproxen Sodium 220 mg/1
Tablet		Granules India LtdANDA
62207-762Naproxen Sodium 220 mg/1
Tablet, Film Coated		Granules India LtdANDA
62207-729Naproxen Sodium 220 mg/1
Tablet		Granules India LtdANDA
62207-761Naproxen Sodium 220 mg/1
Tablet, Film Coated		Granules India LtdANDA
69848-010Naproxen Sodium 220 mg/1
Tablet		Granules USA, Inc.ANDA
37808-631Naproxen Sodium 220 mg/1
Tablet, Film Coated		H E BANDA
37808-652Naproxen Sodium 220 mg/1
Tablet, Film Coated		H E BANDA
37808-713Naproxen Sodium 220 mg/1
Tablet, Film Coated		H E BANDA
72036-144Naproxen Sodium 220 mg/1
Tablet, Coated		Harris TeeterANDA
72036-145Naproxen Sodium 220 mg/1
Tablet, Coated		Harris TeeterANDA
53345-042Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdANDA
42507-245Naproxen Sodium 220 mg/1
Tablet, Coated		HYVEE INCANDA
42507-844Naproxen Sodium 220 mg/1
Tablet, Coated		HYVEE INCANDA
30142-954Naproxen Sodium 220 mg/1
Tablet, Coated		Kroger CompanyANDA
41226-609Naproxen Sodium 220 mg/1
Tablet, Coated		Kroger CompanyANDA
50844-604Naproxen Sodium 220 mg/1
Tablet, Film Coated		L.N.K. International, Inc.ANDA
50844-417Naproxen Sodium 220 mg/1
Tablet, Film Coated		L.N.K. International, Inc.ANDA
71141-182Naproxen Sodium 220 mg/1
Tablet, Film Coated		Lidl US LLCANDA
68998-144Naproxen Sodium 220 mg/1
Tablet, Coated		Marc Glassman, Inc.ANDA
68998-145Naproxen Sodium 220 mg/1
Tablet, Coated		Marc Glassman, Inc.ANDA
25000-144Naproxen Sodium 220 mg/1
Tablet		MARKSANS PHARMA LIMITEDANDA
25000-141Naproxen Sodium 220 mg/1
Tablet		MARKSANS PHARMA LIMITEDANDA
41250-313Naproxen Sodium 220 mg/1
Tablet, Film Coated		Meijer Distribution IncANDA
41250-477Naproxen Sodium 220 mg/1
Tablet, Film Coated		Meijer Distribution IncANDA
41250-680Naproxen Sodium 220 mg/1
Tablet, Film Coated		Meijer Distribution IncANDA
41250-818Naproxen Sodium 220 mg/1
Tablet, Film Coated		Meijer Distribution IncANDA
68071-2333Naproxen Sodium 550 mg/1
Tablet		NuCare Pharmaceuticals,Inc.ANDA
59726-174Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		P & L Development, LLCANDA
59726-751Naproxen Sodium 220 mg/1
Capsule		P & L Development, LLCANDA
45802-490Naproxen Sodium 220 mg/1
Tablet, Film Coated		Padagis Israel Pharmaceuticals LtdANDA
72789-543Naproxen Sodium 220 mg/1
Tablet, Film Coated		PD-Rx Pharmaceuticals, Inc.ANDA
72789-389Naproxen Sodium 550 mg/1
Tablet		PD-Rx Pharmaceuticals, Inc.ANDA
43063-909Naproxen Sodium 220 mg/1
Tablet, Film Coated		PD-Rx Pharmaceuticals, Inc.ANDA
85509-1495Naproxen Sodium 550 mg/1
Tablet, Film Coated		PHOENIX RX LLCANDA
68788-7800Naproxen Sodium 550 mg/1
Tablet		Preferred Pharmaceuticals, Inc.ANDA
63187-596Naproxen Sodium 220 mg/1
Tablet, Film Coated		Proficient Rx LPANDA
71205-479Naproxen Sodium 550 mg/1
Tablet, Film Coated		Proficient Rx LPANDA
71205-631Naproxen Sodium 550 mg/1
Tablet		Proficient Rx LPANDA
51013-137Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		PuraCap Pharmaceutical LLCANDA
55700-625Naproxen Sodium 550 mg/1
Tablet, Film Coated		Quality Care Products, LLCANDA
11822-4171Naproxen Sodium 220 mg/1
Tablet, Film Coated		Rite Aid CorporationANDA
11822-6040Naproxen Sodium 220 mg/1
Tablet, Film Coated		Rite Aid CorporationANDA
21130-593Naproxen Sodium 220 mg/1
Tablet, Film Coated		SafewayANDA
21130-061Naproxen Sodium 220 mg/1
Tablet		Safeway, IncANDA
21130-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Safeway, Inc.ANDA
68196-255Naproxen Sodium 220 mg/1
Tablet, Coated		SAM'S WEST INCANDA
50228-433Naproxen Sodium 550 mg/1
Tablet		ScieGen Pharmaceuticals, Inc.ANDA
50228-432Naproxen Sodium 275 mg/1
Tablet		ScieGen Pharmaceuticals, Inc.ANDA
68210-4096Naproxen Sodium 220 mg/1
Tablet, Film Coated, Extended Release		SPIRIT PHARMACEUTICALS,LLCANDA
60760-801Naproxen Sodium 550 mg/1
Tablet		ST. MARY'S MEDICAL PARK PHARMACYANDA
70677-1148Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Strategic Sourcing Services LLCANDA
11673-764Naproxen Sodium 220 mg/1
Tablet		TARGET CORPORATIONANDA
11673-748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		TARGET CorporationANDA
0480-0951Naproxen Sodium 375 mg/1
Tablet, Film Coated, Extended Release		Teva Pharmaceuticals, Inc.ANDA
0480-0953Naproxen Sodium 750 mg/1
Tablet, Film Coated, Extended Release		Teva Pharmaceuticals, Inc.ANDA
0480-0952Naproxen Sodium 500 mg/1
Tablet, Film Coated, Extended Release		Teva Pharmaceuticals, Inc.ANDA
49483-608Naproxen Sodium 220 mg/1
Tablet, Film Coated		TIME CAP LABORATORIES, INCANDA
49483-609Naproxen Sodium 220 mg/1
Tablet, Film Coated		TIME CAP LABORATORIES, INCANDA
63941-445Naproxen Sodium 220 mg/1
Tablet, Coated		VALU MERCHANDISERS COMPANYANDA
63941-444Naproxen Sodium 220 mg/1
Tablet, Coated		VALU MERCHANDISERS COMPANYANDA
0363-0748Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		WalgreensANDA
0363-7510Naproxen Sodium 220 mg/1
Tablet		WalgreensANDA
79903-231Naproxen Sodium 220 mg/1
Tablet, Film Coated		WALMART INC.ANDA
79903-232Naproxen Sodium 220 mg/1
Tablet, Film Coated		WALMART INC.ANDA
67091-140Naproxen Sodium 220 mg/1
Tablet, Coated		WinCo Foods, LLCANDA
67091-138Naproxen Sodium 220 mg/1
Tablet, Coated		WinCo Foods, LLCANDA
21130-948Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Albertsons CompaniesNDA
72288-312Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Amazon.com Services LLCNDA
46122-780Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		AMERISOURCE BERGENNDA
69452-179Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Bionpharma Inc.NDA
69452-284Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Bionpharma Inc.NDA
69452-259Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Bionpharma Inc.NDA
63868-830Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		CHAIN DRUG MARKETING ASSOCIATION INC.NDA
53943-179Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		DISCOUNT DRUG MART, INC.NDA
37808-049Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		HEBNDA
30142-285Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		KROGER COMPANYNDA
41250-225Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		MEIJER DISTRIBUTION INCNDA
68016-056Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Premier Value Alliance LLCNDA
11822-0788Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Rite Aid CorporationNDA
41163-079Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		SUPERVALU INCNDA
11673-651Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		TARGET CorporationNDA
36800-204Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		TOP CARE (Topco Associates LLC)NDA
63941-681Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		VALU MERCHANDISERS COMPANYNDA
49035-382Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		Wal-Mart Stores, Inc.NDA
0363-0102Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		WALGREEN COMPANYNDA
0363-0177Naproxen Sodium 220 mg/1
Capsule, Liquid Filled		WALGREEN COMPANYNDA
47781-153Naproxen Sodium 375 mg/1
Tablet, Film Coated, Extended Release		Alvogen Inc.NDA AUTHORIZED GENERIC
47781-154Naproxen Sodium 500 mg/1
Tablet, Film Coated, Extended Release		Alvogen Inc.NDA AUTHORIZED GENERIC
69420-1375Naproxen Sodium 375 mg/1
Tablet, Film Coated, Extended Release		SA3, LLCNDA AUTHORIZED GENERIC
24979-252Naproxen Sodium 375 mg/1
Tablet, Film Coated, Extended Release		Upsher-Smith Laboratories, LLCNDA AUTHORIZED GENERIC
24979-253Naproxen Sodium 500 mg/1
Tablet, Film Coated, Extended Release		Upsher-Smith Laboratories, LLCNDA AUTHORIZED GENERIC
24979-254Naproxen Sodium 750 mg/1
Tablet, Film Coated, Extended Release		Upsher-Smith Laboratories, LLCNDA AUTHORIZED GENERIC

Naproxen Sodium recalls

Frequently asked questions

What is Naproxen Sodium used for?

Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [ see Warnings and Precautions ( 5 ) ]. Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment…

Who makes Naproxen Sodium?

Naproxen Sodium is listed by 85 labelers in the FDA NDC directory, including A-S Medication Solutions, AAA Pharmaceutical, Inc., AAFES/Your Military Exchanges, Advanced Rx of Tennessee, LLC.

Has Naproxen Sodium been recalled?

The FDA enforcement database lists 5 recalls for Naproxen Sodium, most recently D-0346-2025 (class ii): CGMP Deviations