Label: IBUPROFEN 100- ibuprofen tablet, coated
IBUPROFEN 250- ibuprofen tablet, coated

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

Drug Label Information

Updated September 19, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In Each Tablets)

    Ibuprofen, USP 200 mg (NSAID)

    *Nonsteroidal Anti-Inflammatory Drug

  • Purpose

    pain reliever/fever reducer

  • Use

    temporarily relieves fever and minor aches and pains associated with:

    • common cold
    • backache
    • headache
    • toothache
    • arthritis
    • muscular aches
    • menstrual cramps
  • Warnings

    Allergy Alert

    Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • asthma (wheezing)
    • facial swelling
    • 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 nonsteroidal anti-inflammatory drug (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 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 a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) drug
    • 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
    • long term continuous use may increase the risk of heart attack or stroke

    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
    • 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
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)

    Adults: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

    Children under 12 years: Ask a doctor.

  • Other Information

    • do not use if packet is opened or torn
    • Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
  • Inactive Ingredients

    crosscarmellose sodium1, FD& C Blue #21, FD& C red #401, FD& C Yellow #61, hypromellose1, iron oxide red1, lactose monohydrate1, magnesium stearate1, maltodextrin1, medium chain triglycerides1, microcrystalline cellulose1, polydextrose1, polyethylene glycol1, polyvinyl alcohol1, povidone (K-30)1, silicon dioxide, sodium starch glycolate1, starch, stearic acid1, talc1, titanium dioxide, triacetin1,

    1
    contains one or more of these ingredients
  • Questions?

    1-866-651-3660 Monday-Friday

    8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box

    This product is not manufactured or distributed by
    Pfizer Consumer Healthcare
    Owner of the registered trademark Advil®.

    Product #1102

    Ibuprofen

    Pain Reliever/Fever Reducer

    Active ingredient:
    Ibuprofen

    • Temporary relief from pain, fever and inflammation
    • Soothes muscles aches and minor arthritis pain
    • Non-drowsy, aspirin-free formula

    These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    100 Tablets • 2 Tablets Per Packet

    PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box
  • PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box

    Product #1104

    Ibuprofen

    Pain Reliever/Fever Reducer

    Active ingredient:
    Ibuprofen

    • Temporary relief from pain, fever and inflammation
    • Soothes muscles aches and minor arthritis pain
    • Non-drowsy, aspirin-free formula

    These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    250 Tablets • 2 Tablets Per Packet

    PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 100 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1102-150 in 1 BOX02/02/2000
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209602/02/2000
    IBUPROFEN 250 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1104-1125 in 1 BOX02/02/2000
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209602/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)
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