IBUPROFEN TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

  • Home
  • IBUPROFEN TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

IBUPROFEN TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]
PDF | XML
NDC 76413-313-24
Set ID 2542cbee-3aca-4a2d-b9f8-07a86b0b3a43
Category HUMAN OTC DRUG LABEL
Packager Central Texas Community Health Centers
Generic Name
Product Class
Product Number
Application Number ANDA072096
View All Sections
  • Active ingredient (in each tablet)

    Ibuprofen 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 an 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

    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
    •
    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. (1-800-222-1222)

  • 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

    •
    read all warnings and directions before use
    •
    store at 20-25°C (68-77°F)
    •
    avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Label

    CommUnityCare Federally Qualified Health Centers

    IBUPROFEN
    200MG #24
    TABLETS

    Date:

    Name:
    Dr.

    Take as directed

    123456

    1/1/01

    IBUPROFEN 200MG #24 TABS NDC 76413-313-24

    Batch: 123456
    Lot: 123456
    Exp: 1/1/01
    SUNMARK

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-313(NDC:49348-706)
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-313-241 in 1 CARTON06/24/2003
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209606/24/2003
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-313) , RELABEL(76413-313)
View All Sections

Related Drugs

Search DailyMed Drugs