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Advil®
2016-11-14 06:38:37 来源: 作者: 【 】 浏览:363次 评论:0
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
  • PURPOSE

    Purpose

    Pain reliever/ Fever reducer

  • INDICATIONS & USAGE

    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

    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

    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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

    For most recent product information, visit www.Advil.com
    Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Label

    Advil®

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    FILM-COATED
    IBUPROFEN
    SODIUM

    20 Coated Tablets

    Principal Display Panel - 20 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Tablets

    20 Coated Tablets

    Principal Display Panel - 20 Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 80 Tablet Bottle Label

    Advil®

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    FILM-COATED
    IBUPROFEN
    SODIUM

    80 Coated Tablets

    PRINCIPAL DISPLAY PANEL - 80 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 80 Tablet Bottle Carton

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Tablets

    80 Coated Tablets

    Principal Display Panel - 80 Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 2 Tablet Packet

    Advil®

    Ibuprofen Tablets 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever/Fever Reducer (NSAID)

    2 Coated Tablets
    200 mg Each

    Principal Display Panel - 2 Tablet Packet
  • PRINCIPAL DISPLAY PANEL - 50 Packet Tray

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Tablets

    ✔ Headache

    ✔ Muscular Aches

    ✔ Minor Pain of Arthritis

    ✔ Menstrual Cramps

    ✔ Toothache

    ✔ Fever

    See Full Drug
    Facts information
    on the back of
    this dispenser

    50 PACKETS of
    2 COATED TABLETS EACH

    Principal Display Panel - 50 Packet Tray
  • PRINCIPAL DISPLAY PANEL - 4 Tablet Blister Pack

    Do not use if blister is open or the
    words "ADVIL SAFETY SEALED"
    under blister are missing or torn.

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Go to Advil.com
    for a coupon good on
    your next purchase!

    Tablets

    4 Coated Tablets

    Principal Display Panel - 4 Tablet Blister Pack
  • PRINCIPAL DISPLAY PANEL - 2 x 120 Bottle Carton

    Advil®

    2
    PACK
    2x120
    TABLETS

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Tablets

    FILM-COATED
    IBUPROFEN SODIUM

    240 Coated Tablets
    2 x 120 Count Bottles

    PRINCIPAL DISPLAY PANEL - 2 x 120 Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

    Advil®

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    FILM-COATED
    IBUPROFEN SODIUM

    20 Caplets**

    **capsule-shaped tablets

    Principal Display Panel - 20 Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Caplets**

    20 Coated Caplets**
    **capsule-shaped tablets

    PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 80 Caplet Bottle Label

    Advil®

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    FILM-COATED
    IBUPROFEN
    SODIUM

    80 Caplets**

    **capsule-shaped tablets

    PRINCIPAL DISPLAY PANEL - 80 Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 80 Caplet Bottle Carton

    Advil®

    FILM-COATED
    IBUPROFEN
    SODIUM

    Ibuprofen Tablets, 200 mg
    (Provided as Ibuprofen Sodium 256 mg)
    Pain Reliever / Fever Reducer (NSAID)

    Caplets**

    80 Coated Caplets**
    **capsule-shaped tablets

    PRINCIPAL DISPLAY PANEL - 80 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL  ibuprofen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0133
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM 256 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN (beige) Score no score
    Shape ROUND Size 10mm
    Flavor   Imprint Code Advil;asymmetrical;underline
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0133-20 1 in 1 CARTON 07/08/2013  
    1   20 in 1 BOTTLE; Type 0: Not a Combination Product    
    2 NDC:0573-0133-40 1 in 1 CARTON 07/08/2013  
    2   40 in 1 BOTTLE; Type 0: Not a Combination Product    
    3 NDC:0573-0133-80 1 in 1 CARTON 07/08/2013  
    3   80 in 1 BOTTLE; Type 0: Not a Combination Product    
    4 NDC:0573-0133-02 50 in 1 TRAY 07/08/2013  
    4   2 in 1 PACKET; Type 0: Not a Combination Product    
    5 NDC:0573-0133-04 2 in 1 BLISTER PACK 07/08/2013  
    5   2 in 1 PACKET; Type 0: Not a Combination Product    
    6 NDC:0573-0133-89 1 in 1 CARTON 07/08/2013  
    6   160 in 1 BOTTLE; Type 0: Not a Combination Product    
    7 NDC:0573-0133-81 1 in 1 CARTON 07/08/2013  
    7   100 in 1 BOTTLE; Type 0: Not a Combination Product    
    8 NDC:0573-0133-05 2 in 1 CARTON 07/08/2013  
    8   2 in 1 PACKET; Type 0: Not a Combination Product    
    9 NDC:0573-0133-88 2 in 1 PACKAGE 07/08/2013  
    9   120 in 1 BOTTLE; Type 0: Not a Combination Product    
    10 NDC:0573-0133-41 1 in 1 CARTON 08/12/2015  
    10   40 in 1 BOTTLE; Type 0: Not a Combination Product    
     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA201803 07/08/2013  
    ADVIL  ibuprofen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0134
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM 256 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN (beige) Score no score
    Shape OVAL Size 15mm
    Flavor   Imprint Code Advil;asymmetrical;underline
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0134-20 1 in 1 CARTON 07/08/2013  
    1   20 in 1 BOTTLE; Type 0: Not a Combination Product    
    2 NDC:0573-0134-80 1 in 1 CARTON 07/08/2013  
    2   80 in 1 BOTTLE; Type 0: Not a Combination Product    
     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA201803 07/08/2013  
    Labeler - Pfizer Consumer Healthcare (828831730)
    Registrant - Pfizer Inc (113480771)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company, Consumer Site   829390975 ANALYSIS(0573-0133, 0573-0134) , LABEL(0573-0133, 0573-0134) , MANUFACTURE(0573-0133, 0573-0134) , PACK(0573-0133, 0573-0134) 
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