Label: IBUPROFEN SOFTGELS- ibuprofen 200 mg capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2018

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  • Active ingredient

    Solubilized ibuprofen equal to 200mg 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

    The chances are 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.

    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, or kidney disease

    ■ you have asthma

    ■ 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.

    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 (1-800-222-1222) right away.

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • Adults and children 12 years and older: take 1 softgel every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 softgel, 2 softgels may be used
    • do not exceed 6 softgels in 24 hours, unless directed by a doctor
    • Children under 12 years: ask a doctor
  • Inactive Ingredients

    ammonium hydroxide, FD&C green #3 aluminum lake, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitol sorbitan, sorbitan monooleate

  • Package/Label Principal Display Panel

    XL-DOL ibuprofen 200mg

    XL-DOL ibuprofen 200mg

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  SOFTGELS
    ibuprofen 200 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-363
    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)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-363-401 in 1 CARTON12/22/2014
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920512/22/2014
    Labeler - Selder, S.A. de C.V. (824413629)
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