Label: DOLEX FLEX- ibuprofen capsule, liquid filled

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

Drug Label Information

Updated January 27, 2020

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

  • Drug Facts

  • Active Ingredient

    Active ingredient (in each capsule)Purpose
    Solubilized ibuprofen equal to
    200 mg ibuprofen (NSAID)*...............
    Pain reliever/fever reducer

    * nonsteroidal anti-inflammatory drug

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • temporarily reduces fever
  • Warnings

    Allergy alert:

    Ibuprofen may cause a severeallergic 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

    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).

    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
    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
    • read all warnings and directions before use
    • retain carton for complete product information and warnings
  • Inactive ingredients

    FD&C blue no. 1, FD&C, yellow no.6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sobitan.

  • Questions or comments?

    1-866-359-3478
    (M-F) 9 AM - 5 PM EST or www.pharmadel.com

  • Package Principal Display Panel

    DOLEX® FLEX

    Relief of

    MUSCULAR ACHES

    Solubilized Ibuprofen Capsules, 200 mg

    Pain Reliever / Fever Reducer (NSAID)

    20 SOFTGELS**
    (**Liquid Filled Capsules)

    DF

  • INGREDIENTS AND APPEARANCE
    DOLEX FLEX 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorgreenScorescore with uneven pieces
    ShapeOVALSize19mm
    FlavorImprint Code AT146
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-310-201 in 1 CARTON10/31/2019
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20699910/31/2019
    Labeler - Pharmadel LLC (030129680)