IBUPROFEN TABLET [WALGREENS]

IBUPROFEN TABLET [WALGREENS]
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NDC 0363-9612-01, 0363-9612-05, 0363-9612-26, 0363-9612-50
Set ID 76f15be2-4682-5015-e053-2991aa0af0d2
Category HUMAN OTC DRUG LABEL
Packager WALGREENS
Generic Name
Product Class
Product Number
Application Number ANDA091237
  • 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 pain 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 allergy 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 bad 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 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

    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 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 SAFETY INFORMATION

    Other information

    • read all warnings and directions before use
    • store at 20-25ºC (68-77ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • QUESTIONS

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

  • 50 COUNT 612R

    50 CT 612R

  • 100 COUNT 612R

    100 CT 612R

  • 225 COUNT 612R

    225 COUNT 612R

  • 500 COUNT 612R

    500 CT 612R

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9612
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code 120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9612-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    2NDC:0363-9612-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    3NDC:0363-9612-26225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    4NDC:0363-9612-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123712/11/2018
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(0363-9612)

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