DRAGON TABS (IBUPROFEN 200 MG) TABLET [GENOMMA LAB USA]

DRAGON TABS (IBUPROFEN 200 MG) TABLET [GENOMMA LAB USA]
PDF | XML

NDC 50066-374-40
Set ID ab07e341-51a3-4d8d-b584-0719da994c1c
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA
Generic Name
Product Class
Product Number
Application Number ANDA075010
  • Active ingredient

    Ibuprofen USP, 200mg (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

  • 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 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.

    Do not use

    if you have ever had an allergic reaction to 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, or kidney disease ■ you have asthma ■ 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) or steroid 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 faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts 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
    do not take longer than 10 days, unless directed by a doctor (see Warnings)
    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

    store between 20-25 °C (68-77° F).■ Read all warnings and directions before useDo not use if
    seal under bottle cap is broken or missing.

  • Inactive Ingredients

    colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate,
    microcrystalline cellulose, sodium starch glycolate, titanium dioxide, carnuba wax, lactose, polydextrose, polyethylene glycol

  • Questions or Comments?

    Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

  • Package/Label Principal Display Panel

    Dragon Tabs
    Ibuprofen 200 mg/Ibuprofeno 200mg
    Pain Reliever/Fever Reducer (NSAID)
    Alivia el Dolor/Reduce la fiebre (AINE)

    Temporarily Relieves:
    Backache
    Muscular aches

    Alivio Temporal de:
    Dolor de Espalda
    Dolores Musculares

    40 Tablets/Tabletas

    Z:\SPL-OTC Mono\Genomma\Dragon\Dragon Box.jpg
  • INGREDIENTS AND APPEARANCE
    DRAGON  TABS
    ibuprofen 200 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-374
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE (UNII: J2B2A4N98G)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-374-4040 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product04/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501004/17/2015
    Labeler - Genomma Lab USA (832323534)
    Registrant - Genomma Lab USA (832323534)

Related Drugs