FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [WE CARE DISTRIBUTOR INC.]

FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [WE CARE DISTRIBUTOR INC.]
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NDC 70005-009-02, 70005-009-25, 70005-009-50
Set ID 16b751a9-2f33-4303-b75f-ca0c012a212d
Category HUMAN OTC DRUG LABEL
Packager We Care Distributor Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient(in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purpose

    Pain reliever/Fever reducer


  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • 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:



    • 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

    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

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

    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
    • 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 stools
      • have stomach pain that does not get better
    • 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 right away.


  • DOSAGE & ADMINISTRATION

    • 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

    • each tablet contains: sodium 22 mg
    • read all warnings and directions before use
    • Keep carton or card
    • store at 20 - 25°C (68 - 77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide


  • Questions or Comments

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


  • Principal Display Panel

    NDC 70005-009-25

    SEE NEW WARNINGS AND DIRECTIONS

    We Care

    For Good Health

    COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

    TO OPEN PUSH IN TAB AND PULL OUT

    Ibuprofen 200 mg

    Pain Reliever/Fever Reducer (NSAID)



    • Headache
    • Toothache
    • Minor Pain of Arthritis
    • Fever
    • Muscularache
    • Menstrual Cramps

    Ibuprofen

    *This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

    25 Pouches of 2 Coated Tablets



    Untitled.jpg

  • INGREDIENTS AND APPEARANCE
    FAST PAIN RELIEF 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-009
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-009-024 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-009-2525 in 1 CARTON
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-009-5050 in 1 CARTON
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/02/2015
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(70005-009)

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