Naprelan 375 mg/1

Naproxen Sodium · TABLET, FILM COATED, EXTENDED RELEASE · Upsher-Smith Laboratories, LLC

No Recall History

Plain English

Naprelan is a prescription extended-release tablet containing naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and reduce inflammation. It is taken by mouth and is designed to provide long-lasting relief from conditions such as arthritis, menstrual cramps, and other types of pain.

Key Facts

Brand Name: Naprelan
Generic Name: Naproxen Sodium
NDC Code (Product): 24979-249
Manufacturer: Upsher-Smith Laboratories, LLC
Strength: 375 mg/1
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA020353
Marketing Start: 12/31/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,911 reports

fatigue2,637 reports

off label use2,512 reports

pain2,466 reports

rash2,245 reports

arthralgia2,216 reports

diarrhoea2,204 reports

vomiting2,132 reports

condition aggravated2,107 reports

joint swelling2,065 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NAPRELAN 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 )] . NAPRELAN 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 & Administration

2 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 NAPRELAN and other treatment options before deciding to use NAPRELAN. 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 NAPRELAN, the dose and frequency should be adjusted to suit an individual patient’s needs. 2.2 Rheumatoid Arthritis, Os…

Contraindications

4 CONTRAINDICATIONS NAPRELAN is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] Known hypersensitivity to naproxen or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with naproxen. Table 1: Clinically Significant Drug Interactions with Naproxen Drugs That Interfere with Hemostasis Clinical Impact: Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of NAPRELAN with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.12 ) ]. Aspirin Clinical Impact : A pharmacodynamic (PD) study has demonstrated an interaction in which lower dose naproxen (220 mg/day or 220 mg twice daily) interfered with the antiplatelet effect …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] The most frequent adverse events were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TWi Pharmaceuticals, Inc. at 1-844-518-2989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of …

Frequently Asked Questions

What is Naprelan used for?

Is Naprelan a controlled substance?

Naprelan is not classified as a controlled substance by the DEA.

What is the generic name for Naprelan?

The generic name for Naprelan is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Naprelan 375 mg/1?

The NDC (National Drug Code) for Naprelan 375 mg/1 is 24979-249, listed by Upsher-Smith Laboratories, LLC.

Product NDC

24979-249

Package NDC

24979-249-01

Other Naproxen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)