Flex-Prin

Flex-Prin is an FDA-registered drug product whose active ingredient is IBUPROFEN. It is labelled by Provision Medical Products taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69103-2525, application ANDA079129, label effective 20230105. It is one of 362 FDA drug label records sharing the active ingredient IBUPROFEN. 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.

Across FDA labelling, products containing IBUPROFEN are most often described in connection with: temporarily relieves, minor aches, pains due, pain arthritis, common cold, toothache backache, menstrual cramps, reduces fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever

Directions: • Do not take more than directed. Adults and children 12 years and older • Take 1 tablet every 4 to 6 hours while symptoms • If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless as directed by a doctor. • The smallest effective dose should be used. Children under 12 year • Ask a doctor.

Warnings: Allergy Alert: Ibuprofen may cause a severe allergic reaction which may include: • hives • shock • facial swelling • asthma (wheezing) Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Ibuprofen or other pain relievers/ fever reducers. Ibuprofen may cause stomach bleeding. Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have: • stomach pain • problems or serious side eects 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 any other drug • taking any other product that contains Ibuprofen, or any other pain reliever/fever reducer When using this product give with food or milk if stomach upset occurs. Stop use and ask a doctor if: • an allergic reaction occurs. Seek medical help right away • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • any new symptoms appear • redness or swelling is present in the painful area

FDA lists 362 drug label records with IBUPROFEN 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.

What is Flex-Prin used for?
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever

Who makes Flex-Prin?
Provision Medical Products is the labeler of record for Flex-Prin. 362 FDA label records share the active ingredient IBUPROFEN, 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 Flex-Prin 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 Flex-Prin 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 IBUPROFEN?
Yes. 362 FDA drug label records list IBUPROFEN 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 Flex-Prin 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.