Label: IBUPROFEN tablet, film coated
IBUPROFEN tablet, film coated
IBUPROFEN- ibupfrofen tablet, film coated

  • NDC Code(s): 49483-114-10, 49483-114-17, 49483-114-50, 49483-114-73, view more
    49483-600-01, 49483-600-05, 49483-600-50, 49483-601-00, 49483-601-01, 49483-601-05, 49483-601-10, 49483-601-50
  • Packager: TIME CAP LABORATORIES,INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 22, 2023

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Ibuprofen 200 mg (NSAID)*
    * nonstreoidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain reliever / Fever reducer

  • INDICATIONS & USAGE

    Uses
    temporarily relieves minor aches and pains due to:

    o headache
    o toothache
    o backache
    o menstrual cramps
    o the common cold
    o muscular aches
    o minor pain of arthritis

    temporarily reduces fever

  • WARNINGS

    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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase 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

    Do not use

    • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    • right before or after heart surgery
  • ASK DOCTOR

    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, asthma, or had a stroke
    • you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    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

    When using this product

    • take with food or milk if stomach upset occurs
  • STOP USE

    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 problem or stroke:

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

    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 at 20 weeks or later in 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

    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).

  • DOSAGE & ADMINISTRATION

    Directions
    do not take more than directed
    the smallest effective dose should be used

    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

    Other information

    • read all warnings and directions before use
    • store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • QUESTIONS

    Questions or comments? call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    Ibu 100ct capletIbu 500ct caplet

  • PRINCIPAL DISPLAY PANEL

    Ibu-50-tablets

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    timely-ibu-100s601R-Timely-Ibu-500s-label601R-Timely-Ibu-200s-label601R-timely-ibuprofen-label-1000s

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUND (Biconvex) Size10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-114-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2021
    2NDC:49483-114-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2021
    3NDC:49483-114-17200 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2023
    4NDC:49483-114-73100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123903/22/2016
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorbrownScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-601-006500 in 1 BAG; Type 0: Not a Combination Product03/22/2016
    2NDC:49483-601-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
    3NDC:49483-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
    4NDC:49483-601-50500 in 1 BOTTLE; Type 0: Not a Combination Product03/22/201608/07/2021
    5NDC:49483-601-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/22/201608/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123903/22/2016
    IBUPROFEN 
    ibupfrofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-600
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorbrownScore2 pieces
    ShapeCAPSULESize15mm
    FlavorImprint Code 117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-600-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
    2NDC:49483-600-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
    3NDC:49483-600-50500 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123903/22/2016
    Labeler - TIME CAP LABORATORIES,INC (037052099)
    Registrant - TIME CAP LABORATORIES,INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-601, 49483-600, 49483-114)