Label: IBUPROFEN capsule, liquid filled

  • NDC Code(s): 55910-518-11, 55910-518-15, 55910-518-22, 55910-518-26
  • Packager: DOLGENCORP INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

  • Purpose

    Pain reliever/Fever reducer

    *nonsteroidal anti-inflammatory drug

  • 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 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 delivery.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center 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.
  • Inactive ingredients

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

  • Questions or comments?

    call toll-free 1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

    This product is not manufactured or distributed by the owners of Advil ® LIQUI-GELS ®.

    DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
    100% SATISFACTION GUARANTEED! (888) 309-9030

    L0000741

    R0823

  • 20's Carton

    DG health

    Compare to the active
    ingredient of Advil ®
    LIQUI-GELS ®†

    Ibuprofen

    Capsules, 200 mg
    Pain Reliever/Fever Reducer
    (NSAID)

    200 mg

    20 Softgels**

    (**Liquid Filled Capsules)
    Actual Size

    001

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-518
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code IB1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-518-111 in 1 CARTON10/26/2023
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55910-518-151 in 1 CARTON10/26/2023
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55910-518-22120 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2023
    4NDC:55910-518-26200 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868210/26/2023
    Labeler - DOLGENCORP INC (068331990)
    Registrant - BIONPHARMA INC. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgel Inc.002193829manufacture(55910-518)