Ibuprofen Tablet
FDA Label NDC 84269-2525

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Ibuprofen (NDC 84269-2525). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses:, other, do not use:, ask a doctor before use if:, ask a doctor or pharmacist before use if you are:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • toothache
  • menstrual cramps

Other

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • skin reddening
  • shock
  • 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 had stomach ulcers or bleeding problems
    • take a blood thinning (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: NSAIDs, 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 have ever 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 problems or serious side effects from taking pain relievers or fever reducers
  • 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

Ask A Doctor Or Pharmacist Before Use If You Are:

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

When Using This Product:

  • take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If:

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • weakness in one part or side of body
      • leg swelling
      • slurred speech
      • trouble breathing
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • any new symptoms appear
      • redness or swelling is present in the painful area

If Pregnant Or Breast-Feeding:

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically 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.

Directions

Adults and children 12 years and over:

  • do not take more than directed
  • the smallest effective dose should be used
  • take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
    • Children under 12 years: ask a doctor

Other Information

  • read all product information before using
  • tamper evident. Do not use if packet is torn or opened
  • store between 68°-77°F (20°-25°C)
  • avoid excessive heat 104°F (40°C)
  • use by expiration date on package

Inactive Ingredients

carnauba wax, silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel – 250 Tablet Box Label

2525

Flex-Prin

Ibuprofen

Compare to Advil

  • Fast Acting Fever Reducer
  • Relieves Headaches & Joint Pains
  • Compare to Advil
  • The Provision

    First Aid

    Line™

    BY WILDMAN

    Principal Display Panel – 250 Tablet Box Label (Fle04 0000 01)

    Principal Display Panel – 250 Tablet Box Label (Fle04 0000 01)

* Please review the disclaimer below.