Label: ADVIL LIQUIGELS- ibuprofen capsule, liquid filled

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

Drug Label Information

Updated November 4, 2019

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

  • Drug Facts

  • 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 • the common cold • muscular aches • minor pain of arthritis • menstrual 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

    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, or 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    • you expereince 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
    • 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.

  • 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

    coconut oil, FD&C green no. 3, gelatinm lecithin (soyabean), pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

  • Questions or comments?

    Call toll free 1-800-88-ADVIL

  • Package Labeling:

    Advil Liquigels

  • INGREDIENTS AND APPEARANCE
    ADVIL LIQUIGELS 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-148(NDC:0573-0169)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorgreen (Transparent green to blue green) Scoreno score
    ShapeCAPSULE (oblong softgel) Size20mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-148-011 in 1 CARTON09/20/2016
    14 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040209/20/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-148) , repack(67751-148)