IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]

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IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]
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NDC 50844-291-01, 50844-291-02, 50844-291-03, 50844-291-08, 50844-291-10, 50844-291-11, 50844-291-12, 50844-291-13, 50844-291-14, 50844-291-15, 50844-291-16, 50844-291-29
Set ID 57b39311-bc20-ace6-75a9-a07a9311b373
Category HUMAN OTC DRUG LABEL
Packager L.N.K. International, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA075010
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  • Active ingredient (in each brown tablet)

    Ibuprofen USP,
    200 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • menstrual cramps
      • toothache
      • the common cold
      • backache
      • headache
      • muscular aches
      • minor pain of arthritis
    • temporarily reduces fever
  • Warnings

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

    • shock
    • skin reddening
    • asthma (wheezing)
    • rash
    • facial swelling
    • hives
    • 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

    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    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 any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • 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
      • leg swelling
      • slurred speech
      • weakness in one part or side of body
    • 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 (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 over: 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)
    • avoid excessive heat 40°C (104°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal Display Panel

    Quality
    +     Plus

    NDC 50844-291-15

    †Compare to active ingredient in Advil® Tablets

    IBUPROFEN TABLETS
    USP, 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    50 Coated Tablets

    ACTUAL
    SIZE

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Advil® Tablets.
    50844            REV0618A29115

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788
    USA

    Quality Plus 44-291

    Quality Plus 44-291

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-291
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-291-021 in 1 CARTON05/24/1988
    112 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50844-291-081 in 1 CARTON05/24/1988
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50844-291-011 in 1 CARTON05/24/1988
    330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:50844-291-101 in 1 CARTON05/24/1988
    440 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:50844-291-111 in 1 CARTON05/24/1988
    560 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:50844-291-121 in 1 CARTON05/24/1988
    6100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:50844-291-291 in 1 CARTON05/24/1988
    7150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:50844-291-131 in 1 CARTON05/24/1988
    8250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:50844-291-151 in 1 CARTON05/24/1988
    950 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:50844-291-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
    11NDC:50844-291-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
    12NDC:50844-291-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501005/24/1988
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(50844-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(50844-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(50844-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(50844-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(50844-291)
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