IBUPROFEN CAPSULE, LIQUID FILLED [RITE AID CORPORATION]

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IBUPROFEN CAPSULE, LIQUID FILLED [RITE AID CORPORATION]
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NDC 11822-0131-1, 11822-0131-2, 11822-0131-3, 11822-0131-4
Set ID 3746c3ab-4c89-4b0d-bfc0-7227e0390dfc
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class
Product Number
Application Number ANDA203599
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  • 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 20-25°C (68-77°F)
    •
    avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    ammonium hydroxide, caprylic and capric acid triglycerides, FD&C green No. 3, gelatin, isopropyl alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient of Advil® Liqui-Gels®

    SEE NEW WARNINGS

    IBUPROFEN

    LIQUID GELS**

    SOLUBILIZED IBUPROFEN CAPSULES, 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    ACTUAL SIZE

    20 LIQUID GELS**

    **LIQUID FILLED CAPSULES

    13183-ibuprofen.jpg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0131
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREEN (Light Green) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0131-11 in 1 CARTON06/23/2017
    180 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11822-0131-21 in 1 CARTON06/16/2017
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11822-0131-41 in 1 CARTON07/11/2017
    3160 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11822-0131-3300 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2017
    5NDC:11822-0131-51 in 1 CARTON03/20/2020
    520 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20359906/16/2017
    Labeler - Rite Aid Corporation (014578892)
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