Label: IBUPROFEN capsule, liquid filled

  • NDC Code(s): 70000-0571-1, 70000-0571-2, 70000-0571-3
  • Packager: Cardinal Health (Leader) 70000
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 10, 2023

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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
      • muscular aches
      • minor pain of arthritis
      • toothache
      • backache
      • the common cold
      • muscular cramps
    • 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 problem or stroke:
      • chest pain
      • slurred speech
      • trouble breathing
      • leg swelling
      • weakness in one part or side of body
    • 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during del

    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 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° to  25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F). Protect from light.
    • swallow whole; do not crush, chew, or dissolve
  • Inactive ingredients

    FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

  • Questions & Comments

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    COMPARE TO ADVIL® LIQUI-GELS® active ingredient†

    Ibuprofen

    Capsules, 200 mg

    Pain Reliever / Fever Reducer (NSAID)

    Gluten-Free

    Paraben-Free

    SOFTGELS**

    (**Liquid-Filled Capsules)

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    †This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Advil® Liqui-Gels®.

    DISTRIBUTED BY

    CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

  • Product Label

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

    LEADER Ibuprofen 200 mg Softgels

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0571
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code IB200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0571-380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2021
    2NDC:70000-0571-11 in 1 BOX04/30/2021
    220 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:70000-0571-21 in 1 BOX04/30/2021
    340 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868204/30/2021
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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