Label: IBUPROFEN tablet, coated

  • NDC Code(s): 41226-601-01, 41226-601-05, 41226-601-20, 41226-601-25, view more
    41226-601-42
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 3, 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)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain reliever/Fever reducer

  • INDICATIONS & USAGE

    Uses
    •temporarily relieves minor aches and pains due to:
    backache
    headache
    menstrual cramps
    minor pain of arthritis
    muscular aches
    the common cold
    toothache
    •temporarily reduces fever

  • WARNINGS

    Warnings
    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
    •asthma (wheezing)
    •blisters
    •facial swelling
    •hives
    •rash
    •shock
    •skin reddening.
    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
    •you have problems or serious side effects from taking pain relievers or fever reducers
    •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, 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
    •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

    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? 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    601R-Kroger-100s-label601R-Kroger-100s-ifc601R-Kroger-24s-label601R-Kroger-250s-label601R-Kroger-200s-label601R-Kroger-50s-label601R-Kroger-50s-ifc601R-Kroger-24s-ifc

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-601
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUND (biconvex film coated tablets) Size10mm
    FlavorImprint Code TCL;114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-601-421 in 1 CARTON04/10/2021
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41226-601-051 in 1 CARTON06/12/2021
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41226-601-011 in 1 CARTON06/12/2021
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41226-601-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2021
    5NDC:41226-601-25250 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2021
    Labeler - Kroger Company (006999528)
    Registrant - Time Cap Laboratories, Inc. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-601)