Label: IBUPROFEN tablet

  • NDC Code(s): 69848-011-24, 69848-012-10, 69848-012-24, 69848-012-25
  • Packager: Granules USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 19, 2023

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

  • Active ingredient (For Tablet)

    (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Active ingredient (For Caplet)

    (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    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

  • 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 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 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 the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions (For Tablets)

    ■ 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

  • Directions (For Caplets)

    ■ do not take more than directed

    ■ the smallest effective dose should be used

    adults and children 12 years and older

    ■ take 1 caplet every 4 to 6 hours while symptoms persist

    ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used

    ■ do not exceed 6 caplets in 24 hours, unless directed by a doctor

    children under 12 years

    ■ ask a doctor

  • Other information

    ■ store between 20-25°C (68-77°F). [See USP Controlled Temperature]

    ■ avoid excessive heat above 40°C (104°F)

  • 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?

    call 1-877-770-3183 weekdays 9:00 AM to 4:30PM EST.

  • Tablets

    24 count100 count250 count

  • Caplets

    24 count

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorbrown (Reddish Brown color Tablets) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-012-2424 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    2NDC:69848-012-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    3NDC:69848-012-25250 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917407/01/2019
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-011
    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)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorbrown (Reddish Brown tablets) Scoreno score
    ShapeOVAL (Caplet shaped Tablets) Size14mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-011-2424 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917407/01/2019
    Labeler - Granules USA, Inc. (137098864)