Medique Mediproxen
Medique Mediproxen is an FDA drug label for the active ingredient NAPROXEN SODIUM manufactured by Sportpharm LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260424.
- Generic name
- NAPROXEN SODIUM
- Manufacturer
- Sportpharm LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 85766-121
- Application
- ANDA079096
- Label effective
- 20260424
About this product
Medique Mediproxen is an FDA-registered drug product whose active ingredient is NAPROXEN SODIUM. It is labelled by Sportpharm LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85766-121, application ANDA079096, label effective 20260424. It is one of 81 FDA drug label records sharing the active ingredient NAPROXEN SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing NAPROXEN SODIUM are most often described in connection with: temporarily relieves, minor aches, pains due, pain arthritis, backache menstrual, cramps headache, common cold, reduces fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves minor aches and pains due to minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Dosage & Administration
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults: (12 years of age and older) take 1 tablet every 8 to 12 hours while symptoms last. for the first dose you may take 2 tablets within the first hour. do not exceed 2 tablets in any 8 to 12 hour period do not exceed 3 tablets in a 24 hour period Children under 12 years: ask a doctor
Warnings
Warnings Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash 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: are age 60 or older have stomach ulcers or bleeding problems take a blood thinner (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAID, 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 if you ever have had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs
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View labelHow products containing NAPROXEN SODIUM compare
FDA lists 81 drug label records with NAPROXEN SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Proficient Rx LP | 5 |
| — | — | Bryant Ranch Prepack | 4 |
| — | — | Belmora LLC | 3 |
| — | — | Rite Aid Corporation | 3 |
| — | — | Bionpharma Inc. | 2 |
Frequently asked questions
What is Medique Mediproxen used for?
Uses temporarily relieves minor aches and pains due to minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Who makes Medique Mediproxen?
Sportpharm LLC is the labeler of record for Medique Mediproxen. 81 FDA label records share the active ingredient NAPROXEN SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Medique Mediproxen come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Medique Mediproxen prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing NAPROXEN SODIUM?
Yes. 81 FDA drug label records list NAPROXEN SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Medique Mediproxen been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.