Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 71335-1911-0, 71335-1911-1, 71335-1911-2, 71335-1911-3, view more
    71335-1911-4, 71335-1911-5, 71335-1911-6, 71335-1911-7, 71335-1911-8, 71335-1911-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 0904-6747
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 15, 2021

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

  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer

  • 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 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 chances are 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 ibuprofen or any other pain reliever/fever reducer
    right before or after heart surgery

    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 this benefit of aspirin
    under a doctor’s care for any serious condition
    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 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).

  • 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

    read all warnings and directions before use
    store at 20-25°C (68-77°F)
    avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • HOW SUPPLIED

    NDC: 71335-1911-1: 20 Tablets in a BOTTLE

    NDC: 71335-1911-2: 15 Tablets in a BOTTLE

    NDC: 71335-1911-3: 30 Tablets in a BOTTLE

    NDC: 71335-1911-4: 100 Tablets in a BOTTLE

    NDC: 71335-1911-5: 60 Tablets in a BOTTLE

    NDC: 71335-1911-6: 50 Tablets in a BOTTLE

    NDC: 71335-1911-7: 40 Tablets in a BOTTLE

    NDC: 71335-1911-8: 10 Tablets in a BOTTLE

    NDC: 71335-1911-9: 56 Tablets in a BOTTLE

    NDC: 71335-1911-0: 90 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Ibuprofen 200mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1911(NDC:0904-6747)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1911-120 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    2NDC:71335-1911-215 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    3NDC:71335-1911-330 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    4NDC:71335-1911-4100 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    5NDC:71335-1911-560 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    6NDC:71335-1911-650 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    7NDC:71335-1911-740 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    8NDC:71335-1911-810 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    9NDC:71335-1911-956 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    10NDC:71335-1911-090 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209609/20/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1911) , RELABEL(71335-1911)