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Flex-Prin

ibuprofen · Flex-Prin is a nonsteroidal anti-inflammatory drug (over-the-counter) containing ibuprofen, made by Provision Medical Products.

Type
Over the counter
Drug class
Nonsteroidal Anti-inflammatory Drug
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
ibuprofen
Active ingredients
Ibuprofen
Drug class
Nonsteroidal Anti-inflammatory Drug
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet
Label holder
Provision Medical Products
FDA application
ANDA079129
Label updated
01/05/2023

Active ingredients

-IBUPROFEN 200 MG

Purpose

PAIN RELIEVER/FEVER REDUCER

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

Pregnancy or breastfeeding

Ask a health professional before use. It is especially important not to use Ibuprofen during the last 3 months of pregnancy unless directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid and titanium dioxide.

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet200 mgoral1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 270,058 reports that list ibuprofen, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective24,941
  • Pain19,260
  • Fatigue18,400
  • Nausea17,947
  • Headache16,254
  • Arthralgia13,339
  • Dyspnea12,926
  • Vomiting12,839
  • Diarrhea12,544
  • Dizziness11,053

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • Provision Medical ProductsShown hereANDA079129 · Label 01/05/2023 · NDC 69103-2525Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Flex-Prin: common questions

What is Flex-Prin used for?
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
Is Flex-Prin a prescription drug?
No. Flex-Prin is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Flex-Prin?
Yes. Other FDA-listed products with the same active ingredients include Ibuprofen, Childrens Ibuprofen, Ibuprofen minis, ibuprofen childrens.
Who makes Flex-Prin?
Provision Medical Products lists Flex-Prin with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/05/2023 · Label text is shown as published by the manufacturer. Not medical advice