Ibuprofen 200 Mg Capsule, Liquid Filled
FDA Label NDC 70264-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R J General Corporation for the product Ibuprofen 200 Mg (NDC 70264-044). 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 drug facts, otc - active ingredient, uses, warnings, stomach bleeding warning:, other, 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.

Drug Facts

Otc - Active Ingredient

Active ingredients (in each tablet)Purpose
Solubilized Ibuprofen equal to 200 mg Ibuprofen (NSAID)

nonsteroidal anti-inflammatory drug


(present as the free acid and potassium salt)
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

Warnings

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 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

Other

Heart attack and stroke warming:NSAIDs, except aspirin, increase the risk of 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

  • 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

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 problem or stroke:
        • chest pain
        • trouble breathing
        • weakness in one part or side of body
        • slurred speech
        • leg swelling
          • pain gets worse or lasts more than 10 days
          • fever gets worse or lasts more than 3 days
          • 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 at 20 weeks or later in  pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • 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 at 20-25°C (68-77°F)

  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions Or Comments?

Call toll free 1-800-88-ADVIL


Distributed by:

GSK CH, Warren,

NJ 07059

Packaged and distributed by RJ Corp with the permission of HALEON.

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Solubilized Ibuprofen Capsules 200 mg - NDC 70264-044-01 - Carton Label

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