IBUPROFEN CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]

IBUPROFEN CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]
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NDC 56062-033-27
Set ID b6b28227-6716-4374-9d6c-7381b102cf27
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number ANDA203599
  • Active ingredient (in each capsule)

    Solubilized Ibuprofen equal to 200 mg Ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/Fever reducer

  • Uses

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

    Allergy alert: 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.

  • Do not use

    if you have ever had an allergic reaction to any other pain reliever/fever reducer
    right before or after heart surgery
  • Ask a doctor before use if

    stomach bleeding warning applies to you
    you have problems or serious side effects from taking pain relievers or fever reducers
    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 a doctor or pharmacist before use if you are

    under a doctor’s care for any serious condition
    taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    taking any other drug
  • When using this product

    take with food or milk if stomach upset occurs
  • 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 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
  • 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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
  • Other information

    each capsule contains: potassium 20 mg
    read all warnings and directions before use. Keep carton.
    store at 68-77°F (20-25°C)
    avoid excessive heat above 104°F (40°C)
  • Inactive ingredients

    ammonium hydroxide, caprylic and capric acid triglycerides, gelatin, isopropyl alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Package/Label Principal Display Panel

    ibuprofen liquid gels

    SOLUBILIZED IBUPROFEN CAPSULES, 200 mg PAIN RELIEVER/FEVER REDUCER (NSAID)

    Dye-free and no preservatives

    ACTUAL SIZE

    80 LIQUID GELS**

    **LIQUID-FILLED CAPSULES

    Compare to Advil® Liqui-Gels® active ingredient

    7y4-63-ibuprofen-liquid-gels.jpg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-033
    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)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (clear brown) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L2C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-033-271 in 1 CARTON03/15/2018
    180 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20359903/15/2018
    Labeler - Publix Super Markets Inc (006922009)

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