Label: ASSURED IBUPROFEN- ibuprofen tablet

  • NDC Code(s): 68210-0011-4
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 28, 2019

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

  • Drug Facts

    Drug Facts

  • Active ingredient (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pain 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 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
  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • SPL UNCLASSIFIED SECTION

    Heart attack and stroke warning NSAID's except
    aspirin increases the risk of heart attack, 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 ibuprofen or 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 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
    ¬ 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
    ¬ you have symptoms of heart problems or stroke:

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • STOP USE

    ¬ chest pain ¬ trouble breathing
    ¬ leg swelling ¬ slurred speech
    ¬ weakness in one part or side of body
    ¬ 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

  • 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.

    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 caplet
    every 4 to 6 hours while symptoms persist
    ¬ if pain or fever does not respond to 1 caplet, 2
    caplets may be used
    ¬ do not exceed 6 caplets in 24 hours, unless directed
    by a doctor
    ¬ children under 12 years: ask a doctor

  • Other information

    ¬ read all warnings and directions before use.
    ¬ store between 20°-25°C (68°-77°F)
    ¬ avoid excessive heat above 40°C (104°F)

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • Inactive ingredients

    colloidal silicon
    dioxide, FD&C Yellow #6, hypromellose, maize
    starch, polydextrose, polyethylene glycol,
    povidone k30, pregelatinized starch, sodium
    starch glycolate, stearic acid, titanium dioxide.

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    ASSURED IBUPROFEN
    Compare to active ingredient in Mortin® IB CAPLETS †
    NDC 68210-0011-4
    Ibuprofen
    Ibuprofen Tablets USP, 200 mg
    Pain Reliever/Fever Reducer (NSAID)

    Actual Size
    40 Caplets
    †This product is not manufactured or distributed
    by Johnson & Johnson Corporation, owner of the
    registered trademark Motrin® IB Caplets

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0011-41 in 1 CARTON02/25/2019
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20231202/25/2019
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India LTD.918609236manufacture(68210-0011)