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Pain Relief (P and L Development of New York Corporation)

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TABLET, COATED 10 TABLET, COATED in 1 VIAL (59726-117-10) Label Information

Complete Pain Relief Information

  • Active Ingredient (in each tablet)

    Ibuprofen USP, 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

  • 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 oder
    • have had stomach ulcers or bleeding problems
    • take blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks everyday while using this prdouct
    • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed.

    Do not use
    • if you 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 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

    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 stoolos
      • have stomach pain that does not get better
      • Pain gets worse or last more than 10 days
      • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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 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 20o- 25o C (68o- 77o F)
    • read all warnings and directions before use.

  • Inactive Ingredients

    colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin.


  • Questions or comments?

    Call toll free 1-877-753-3935 Monday through Friday 9AM- 5PM EST


  • Principal Display Panel

    Pain Relief

    Ibuprofen Tablets USP, 200 mg

    Pain Reliever/ Fever Reducer (NSAID)*

    †Compare to the active ingredient in ADVIL®

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®

    Product of INDIA

    DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    PL Developments

    Westbury, NY 11590, USA


  • Product Label

    PLD Pain Relief tablets

    Ibuprofen Tablets 200 mg


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-117
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color BROWN (reddish) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code G2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-117-10 10 in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079174 08/13/2012
    Labeler - P and L Development of New York Corporation (800014821)