Naproxen Sodium Tablets USP 220 mg: Uses, Side Effects and Dosage

What is NAPROXEN SODIUM TABLETS USP 220 MG used for?

• Trust NAPROXEN SODIUM TABLETS USP 220 MG for providing fast and effective relief of pain such as arthritis pain and pain of inflammation.
• NAPROXEN SODIUM TABLETS USP 220 MG relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions.
• NAPROXEN SODIUM TABLETS USP 220 MG also relieves joint and body pain, muscular ache, muscle sprains and strains, backache, minor aches, headaches, migraine pain, menstrual cramps, pain of minor surgery, toothaches, pain of dental extractions, pain associated with the common cold and reduces fever.
• Clinical studies show long lasting relief for up to 12 hours.

How does NAPROXEN SODIUM TABLETS USP 220 MG work?

NAPROXEN SODIUM TABLETS USP 220 MG is a pain reliever and fever reducer. NAPROXEN SODIUM TABLETS USP 220 MG works both at the site of pain and in your central nervous system. NAPROXEN SODIUM TABLETS USP 220 MG starts to work fast and treats pain where it starts.

What are the ingredients in NAPROXEN SODIUM TABLETS USP 220 MG?

Medicinal ingredients: Naproxen sodium

Non-medicinal ingredients: FD&C Blue No. 2 Aluminum Lake, Hypromellose, Magnesium stearate, Microcrystalline cellulose, PEG, Povidone, Purified water, Talc and Titanium dioxide.

NAPROXEN SODIUM TABLETS USP 220 MG comes in the following dosage forms:

Tablet: 220 mg

Do not use NAPROXEN SODIUM TABLETS USP 220 MG if:

• You are:

  • allergic to naproxen, naproxen sodium, or any ingredient in the formulation
  • allergic to acetylsalicylic acid (ASA), other salicylates or other nonsteroidal anti- inflammatory drugs (NSAIDs)

  • in your third trimester of pregnancy

  • right before or after heart surgery

• You have:

  • an active peptic ulcer, a history of recurrent ulceration, or active gastrointestinal bleeding
  • inflammatory bowel disease
  • liver disease (active or severe)
• kidney disease (severe or worsening)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NAPROXEN SODIUM TABLETS USP 220 MG. Talk about any health conditions or problems you may have, including if you:

• Have or have had:

  • asthma or a similar respiratory illness
  • nasal polyps
  • itchy skin and hives
  • history of gastrointestinal disease
  • high blood pressure
  • a blood clotting disorder
  • heart disease/failure
  • any other serious disease

• Are:

  • trying to conceive
  • in your first or second trimester of pregnancy
  • breastfeeding

Other warnings you should know about: Stomach bleeding warning: This may cause stomach bleeding.

Symptoms may include:

• feeling faint, vomiting blood, bloody or black stools.

The chance of stomach bleeding is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug

• take with other drugs containing an NSAID like acetylsalicylic acid

  • (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs
  • have 3 or more alcoholic drinks every day while using this product.

Allergy alert: Stop use and get medical help right away if you have ▪hives ▪swelling of eyes and mouth ▪wheezing ▪shock ▪skin reddening ▪blisters ▪rash

When using this product:

• 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:

• fever lasts more than 3 days
• pain lasts more than 5 days
• symptoms get worse or new ones appear

Driving and using machines: If you become drowsy, dizzy or lightheaded do not drive or operate machinery and contact your doctor or pharmacist.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NAPROXEN SODIUM TABLETS USP 220 MG:

• Anticoagulants (to decrease blood clotting)
• Antihypertensive drugs for your heart (including ACE inhibitors and beta-blockers)
• Cyclosporine
• Diuretics (“water pills”)
• Glucocorticoids
• Lithium
• Low dose ASA for doctor supervised daily preventive therapy (e.g.
• ASPIRIN® 81mg)
• Methotrexate
• NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)

• Taking NAPROXEN SODIUM TABLETS USP 220 MG with a meal may slightly delay its absorption.

Do not use this product if you are taking acetylsalicylic acid (ASA) for preventive therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere with the preventive benefits of ASA.

How to take NAPROXEN SODIUM TABLETS

USP 220 MG:

Drink a full glass of water with each dose. Do not use in children under 12 years.

Usual dose:

Adults (12 - 65 years): 1 caplet every 8 - 12 hours. Adults over 65 years: 1 caplet every 12 hours. Do not take more than 2 caplets in a 24 hour period.

Overdose:

Missed dose:

If you miss taking your dose on time, do not worry; take your dose when you remember. Do not exceed more than two doses in 24 hours.

What are possible side effects from using NAPROXEN SODIUM TABLETS USP 220 MG?

These are not all the possible side effects you may have when taking NAPROXEN SODIUM TABLETS USP 220 MG. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, NAPROXEN SODIUM TABLETS USP 220 MG may occasionally produce unwanted side effects. Stop use and contact a doctor or pharmacist if you experience: heartburn, nausea, vomiting, ringing or buzzing in the ears, bloating, diarrhea or constipation.

Serious side effects and what to do about them

If you think you, or a person you are caring for, have taken too much NAPROXEN SODIUM TABLETS USP 220 MG , contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store at 15-30^oC.

• CAUTION: This package contains enough drug to seriously harm a child. Keep out of reach and sight of children

If you want more information about NAPROXEN SODIUM TABLETS USP 220 MG:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the
• Patient Medication Information by visiting the Health Canada Drug Product Database website

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html ); the manufacturer’s website www.rpglifesciences.com or by calling -+1-905-420-7407

Canadian Distributor/Importer:

The Shandex Sales Group Limited,

1100 Squires Beach Road, Pickering,

ON L1W 3N8 Canada.

Date of Authorization:

[2025-10-03]

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health- canada/services/drugs-health- products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.