IBUPROFEN 200MG TABLET, FILM COATED [ALLEGIANT HEALTH]

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IBUPROFEN 200MG TABLET, FILM COATED [ALLEGIANT HEALTH]
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NDC 69168-390-30
Set ID 51e95588-39af-40d6-9924-e98d42af15b9
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number ANDA077349
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  • Active ingredient (in each caplet)

    Ibuprofen USP, 200mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

  • 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 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  

    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

    Ask a doctor or pharmacist 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 

    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

    Pregnancy/Breastfeeding

    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

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

  • Directions

    • 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)
    • do not use if seal under bottle cap is broken or missing
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or Comments?

    Call 1-888-952-0050

    Monday through Friday 9AM – 5PM EST

  • Principal Display Panel

    Ibuprofen 200mg Orange

    Ibuprofen 200mg Orange


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 200MG 
    ibuprofen 200mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-390
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-390-301 in 1 CARTON12/23/2014
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07734912/23/2014
    Labeler - Allegiant Health (079501930)
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