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Ibuprofen (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-06) Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-04) > 250 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-05) Label Information
TABLET, COATED 250 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-08) Label Information
TABLET, COATED 2 BOTTLE, PLASTIC in 1 CARTON (57344-109-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information

Complete Ibuprofen Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each tablet)

    Ibuprofen, USP 200 mg (NSAID1)


    1
    • nonsteroidal anti-inflammatory drug

  • 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

  • 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

    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, 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
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • 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 right away.


  • 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 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)
    • avoid excessive heat above 40°C (104°F)
    • read all warnings and directions before use
    • retain carton for complete product information

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048


  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    RESTORE u

    NDC 57344-109-03

    †COMPARE TO THE ACTIVE
    INGREDIENT IN ADVIL®

    Ibuprofen
    Tablets, USP 200 mg

    Pain Reliever, Fever Reducer

    (NSAID)

    100 COATED TABLETS

    Principal Display Panel - 100 Tablet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-109(NDC:57910-401)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    starch, corn (UNII: O8232NY3SJ)  
    dextrose monohydrate (UNII: LX22YL083G)  
    hypromelloses (UNII: 3NXW29V3WO)  
    ferric oxide red (UNII: 1K09F3G675)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    magnesium stearate (UNII: 70097M6I30)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    povidone K30 (UNII: U725QWY32X)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    sodium starch glycolate type a corn (UNII: AG9B65PV6B)  
    stearic acid (UNII: 4ELV7Z65AP)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code IBU;200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-109-01 1 in 1 CARTON
    1 24 in 1 BOTTLE, PLASTIC
    2 NDC:57344-109-02 1 in 1 CARTON
    2 50 in 1 BOTTLE, PLASTIC
    3 NDC:57344-109-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-109-04 1 in 1 CARTON
    4 250 in 1 BOTTLE, PLASTIC
    5 NDC:57344-109-10 2 in 1 CARTON
    5 100 in 1 BOTTLE, PLASTIC
    6 NDC:57344-109-08 250 in 1 BOTTLE, PLASTIC
    7 NDC:57344-109-05 500 in 1 BOTTLE, PLASTIC
    8 NDC:57344-109-06 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 12/04/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-109)