IBUPROFEN TABLET [WALGREENS]

IBUPROFEN TABLET [WALGREENS]
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NDC 0363-9600-01, 0363-9600-05, 0363-9600-31, 0363-9600-42, 0363-9600-50
Set ID 746f79aa-3036-1b9b-e053-2a91aa0a1db6
Category HUMAN OTC DRUG LABEL
Packager WALGREENS
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • ACTIVE INGREDIENT

    Solubilized Ibuprofen equal to

    200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    * nonsteroidal anti-inflammatory drug

  • ibuprofen 200 mg Caplets -600R INACTIVE INGREDIENTS

    Colloidal silicon dioxide, croscarmellose sodium, iron oxice red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • DOSAGE & ADMINISTRATION

    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 symptom persist
    • If pain 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

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pain due to :

    • headache
    • toothache
    • backache

    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis

    Temporarily reduces fever

  • PURPOSE

    PAIN RELIEVER/ FEVER REDUCER

  • 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 a 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 NSAIDs (aspirin, ibuprofen, naproxen, or others)
    have 3 or more alcoholic drinks every day while using this product
    the more or for a longer time than directed

    Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

  • KEEP OUT OF REACH OF CHILDREN

    IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

  • Ibuprofen Caplets 200 mg 600R - 24 count

    24  count label

  • ibuprofen 200 mg caplet 600R 50 COUNT

    50 COUNT LABEL

  • Ibuprofen 200 MG CAPLETS 600R 100 COUNT

    100 COUNT LABEL

  • ibuprofen 200 mg caplets 600R 300 count label

    30-0 count label

  • ibuprofen 200 mg caplets 600R 500 COUNT

    500 COUNT LABEL

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9600
    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)  
    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
    ColorbrownScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9600-4224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    2NDC:0363-9600-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    3NDC:0363-9600-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    4NDC:0363-9600-31300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/11/2018
    5NDC:0363-9600-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123912/11/2018
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(0363-9600)

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