Label: IBUPROFEN, CASEYS 4GOOD- ibuprofen tablets tablet, film coated

  • NDC Code(s): 66715-6307-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 6, 2023

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

  • Drug facts

    ​Drug facts

  • Active ingredient (in each tablet)

    Active ingredient (in each tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Purpose

    Pain reliever/fever reducer

  • Uses

    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

    Warnings

    Allergy alert

    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

    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

    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

    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

    Ask a doctor before use if

    • you have problems or serious side effects from taking pain relievers or fever reducers
    • the stomach bleeding warning applies to you
    • 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

    Ask a doctor or pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • have bloody or black stools
    • feel faint
    • vomit blood
    • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of the 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

    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

    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)

  • Directions

    Directions

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

    Other information

    • store between 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    Inactive ingredients

    colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Questions or comments? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • Ibuprofen 50ct, Casey's 4good TM

    SEE NEW WARNINGS

    Ibuprofen
    Tablets USP, 200 mg (NSAID)*

    Pain Reliever/Fever Reducer

    Compare to the
    active ingredient in
    Advil Tablets**

    [tablet image]

    actual

    size

    [casey's logo]

    50 COATED TABLETS

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN, CASEYS 4GOOD 
    ibuprofen tablets tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6307-41 in 1 CARTON08/01/2023
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917408/01/2023
    Labeler - Lil' Drug Store Products, Inc. (093103646)