Ibuprofen (nsaid)
FDA Label NDC 21695-065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Ibuprofen (nsaid) (NDC 21695-065). 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, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed By:

Ameal Pharmaceuticals

Glasgow, KY 42141

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Active Ingredient

(in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

        • you have problems or serious side effects from taking pain relievers or fever reducers
        • the stomach bleeding warning applies to you
        • you have a history of stomach problems such as heartburn
        • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
        • you have asthma
        • 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
          • taking any other drug containing an NSAID (prescription or nonprescription)
          • taking a blood thinning (anticoagulant) or steroid drug

            • When using this product

            • take with food or milk if stomach upset occurs
            • long term continuous use may increase the risk of heart attack or stroke

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

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

Directions

  • do not take more than directed
  • the smallest effective dose should be used
    • Adults and children
    12 years and older
    • 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

  • Store between 20 - 25°C (68 - 77°F)
  • Read all warnings and directions before use

Inactive Ingredients

  • Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch Corn, Titanium Dioxide
  • Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide

     

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