IBUPROFEN CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC]

IBUPROFEN CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC]
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NDC 49483-610-44
Set ID e0a8315a-80a5-4be3-aad1-3d01f00df494
Category HUMAN OTC DRUG LABEL
Packager TIME CAP LABORATORIES, INC
Generic Name
Product Class
Product Number
Application Number ANDA079205
  • ACTIVE INGREDIENT

    Solubilized Ibuprofen equal to
    200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    * nonsteroidal anti-inflammatory drug

  • INACTIVE INGREDIENT

    AMMONIA, FD&C GREEN #3, GELATIN, FERROSOFERRIC OXIDE, MEDIUM CHAIN TRIGLYCERIDES, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, POTASSIUM HYDROXIDE, WATER, SHELLAC, SORBITAN MONOOLEATE, SORBITAN

  • 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 capsule every 4 to 6 hours while symptoms persist

    if pain or fever does not respond to 1 capsule, 2 capsules may be used

    do not exceed 6 capsules 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 alerts: 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-610-4440 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920512/23/2015
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-610)

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