Label: CLEAR CHOICE IBUPROFEN - ibuprofen tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Ibuprofen USP, 200mg (NSAID)
    nonsteroidal anti-inflammatory drug  

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • 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
    Close
  • 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
    Close
  • Do not use

    if you have ever had an allergic reaction to other pain reliever/fever reduce

    right before or after heart surgery

    Close
  • Ask a doctor before use if

    • 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
    Close
  • Ask a doctor or pharmacist before use if you are

    • taking aspirin to prevent 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
    Close
  • 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
    Close
  • 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
    Close
  • 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.

    Close
  • 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).

    Close
  • 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 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
    Close
  • Other information

    • store between 20-25 degrees Celsius (68-77 degrees Fahrenheit).
    • Read all warnings and directions before use
    • Do not use if seal under bottle cap is broken or missing.
    Close
  • Inactive ingredients

    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, Starch (Corn), Titanium Dioxide

    Close
  • Questions or Comments

    Call 1-888-634-5522 Monday through Friday 9AM - 5PM EST.

    Close
  • Package Label

    Clear Choice

    IBUPROFEN

    MODERN PAIN MEDICINE

    PAIN AND FEVER RELIEF
    CONTAINS NO ASPIRIN
    CAFFEINE FREE

    Compare to Advil (R)

    100 Tablets
    200 mg each

    This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil (R)

    Manufactured for: A.N.I. Toledo, OH 43623 CODE 27541

    Lot No.:

    Exp. Date:

    main label

    drug facts label

    drug facts label

    Close
  • INGREDIENTS AND APPEARANCE
    CLEAR CHOICE IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53185-003
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color brown (brown) Score no score
    Shape ROUND (round) Size 9mm
    Flavor Imprint Code IBU200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53185-003-00 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 10/09/2012
    Labeler - Athlete's Needs Inc (619703945)
    Registrant - Athlete's Needs Inc (619703945)
    Establishment
    Name Address ID/FEI Business Operations
    Athlete's Needs Inc 619703945 manufacture(53185-003)
    Close