IBUPROFEN TABLET [WALGREENS]

IBUPROFEN TABLET [WALGREENS]
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NDC 0363-9611-01, 0363-9611-05, 0363-9611-10, 0363-9611-31, 0363-9611-50
Set ID 76f4cc25-a77e-6245-e053-2a91aa0af7ae
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 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

    Hear 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 problems 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 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,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

  • PRINCIPAL DISPLAY PANEL

    Ibuprofen200mg-walgreens-100ct-Bottle labelIbuprofen200mg-walgreens-50ct-CartonIbuprofen200mg-walgreens-50ct-Bottle labelIbuprofen200mg-walgreens-500ct-Bottle labelIbuprofen200mg-walgreens-100ct-CartonIbuprofen200mg-walgreens-1000ct-Bottle labelIbuprofen200mg-walgreens-300ct-Bottle label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9611
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize15mm
    FlavorImprint Code 115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9611-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    2NDC:0363-9611-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    3NDC:0363-9611-31300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    4NDC:0363-9611-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    5NDC:0363-9611-101000 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(0363-9611)

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