Label: IBUPROFEN tablet

  • NDC Code(s): 69396-145-01
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2023

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

  • Active Ingredient (in each tablet)

    Ibuprofen, 200mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Releiver / Fever Reducer

    nonsteroidal anti-inflammatory drug

  • Do Not Use

    • If you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    • right before or after heart surgery
  • Uses

    Temporarily relieves minor aches and pains due to

    • Common cold
    • headache
    • minor pain of arthritis
    • toothache
    • backache
    • muscular aches
    • menstrual cramps

    temporarily reduces fever

  • Warnings

    Allergy alert

    Ibuprofen may cause severe allergic reactions, 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 a NSAID, which may cause severe stomach bleeding. The chances are higher if you:

    • are age 60 or older
    • have stomach ulcers or bleeding problems
    • take 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 or 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.

    Contains FD+C Yellow No. 5 (tartrazine) as a color additive

  • 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 if you are

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

    • Do not take more than directed.
    • The smallest effective dose should be used

    Adults and children 12 years and older

    • Take 1 tablet every 4-6 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 of age

    • Ask a doctor
  • 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 lsats 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.

  • Other Information

    • Store at 20ºC - 25ºC (68ºF - 77ºF)
    • Do not use if printed packet is torn or punctured.

    TAMPER EVIDENT child resistant packets. Do not use any opened or torn packets.

  • Inactive Ingredients

    Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

  • Questions or Comments?

    Call 1-888-296-9067

    IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.

  • When using this product

    Take with food or milk if stomach upset occurs

  • Distributed By:

    Distributed By:

    Trifecta Pharmaceuticals USA®

    Ft. Lauderdale, FL. 33301 USA

    1-888-296-9067

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®

    Reorder No. 2022

    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    globe ibuprofin 200mg 50pk child resistant CDER

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-145
    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. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code BI06
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-145-0150 in 1 BOX08/08/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20709508/08/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)