Ibuprofen
FDA Label NDC 59105-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J.p Business Enterprise for the product Ibuprofen (NDC 59105-002). 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 other, active ingredient (in each capsule), purpose, uses, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

Active Ingredient (In Each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)

nonsteroidal anti-inflammatory drug

(present as the free acid and potassium salt)

Purpose

Pain reliever/fever reducer

Uses

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

Allergy Alert

Ibuprofen 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 a nonsteroidal anti-inflammatory drug (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

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

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • you are taking a diuretic

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 ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When Using This Product

  • take with food or milk if stomach upset occurs
  • the 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

  • 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
    • 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
    • redness or swelling is present in the painful area
    • any new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor

Other Information

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

Ammonium hydroxide, FD&C green no. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitan monooleate, Sorbitol sorbitan

Questions Or Comments?

1-888-333-9792

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VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient
in ADVIL® LIQUI-GELS®*

IBUPROFEN softgels

LIQUID FILLED IBUPROFEN CAPSULES, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

10 SOFTGELS

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Principal Display Panel (10 Softgel Bottle Carton)

* Please review the disclaimer below.