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

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

NDC 76413-345-01
Set ID 0765c4f9-9691-4acb-aa00-0bf9e63b4726
Category HUMAN OTC DRUG LABEL
Packager Central Texas Community Health Centers
Generic Name
Product Class
Product Number
Application Number ANDA075010
  • Active ingredient (in each brown 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
      • 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:

    • shock
    • hives
    • facial swelling
    • asthma (wheezing)
    • 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

    • 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 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

    • 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
    • redness or swelling is present in the painful area
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur

    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 use 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 take more than 6 tablets in 24 hours unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • store at controlled room temperature
    • avoid excessive heat 40°C (104°F)
  • Inactive ingredients

    carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

    Questions or comments?

    Call 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Box Label

    CommUnityCare Federally Qualified Health Centers

    IBUPROFEN
    200MG
    TABS #100

    Date:

    Name:
    Dr.

    TAKE AS DIRECTED.

    1/1/01

    123456

    IBUPROFEN 200MG TABS #100 NDC 76413-345-01

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

    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 Box Label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-345(NDC:57896-941)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-345-011 in 1 BOX01/01/2004
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501001/01/2004
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-345) , RELABEL(76413-345)

Related Drugs