Label: IBUPROFEN tablet

  • NDC Code(s): 0536-1390-47, 0536-1390-48
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2023

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 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 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.

    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 tabletsmay be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor ■ children under 12 years: • ask a doctor

  • 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)
    ■ tamper evident sealed packets ■ do not use any opened or torn packets

  • 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 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • PDP

    Ibu cap

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1390
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred ((Reddish Brown)) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1390-48100 in 1 CARTON; Type 0: Not a Combination Product12/31/2024
    2NDC:0536-1390-472 in 1 PACKET; Type 0: Not a Combination Product08/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917408/25/2023
    Labeler - Rugby Laboratories (079246066)