Label: ADVIL MENSTRUAL PAIN- ibuprofen sodium tablet, coated

  • NDC Code(s): 0573-0230-20, 0573-0230-40
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 10, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

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


    1
    nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever/Fever reducer

  • Uses

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

    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

    • 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, asthma, or had a stroke
    • 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

    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
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • 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.

  • 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

    • 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 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 or comments?

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

    For most recent product information, visit www.Advil.com

  • PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Label

    Advil®

    menstrual
    PAIN

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

    READ AND KEEP CARTON
    FOR COMPLETE WARNINGS
    AND INFORMATION

    40
    Tablets

    PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Carton

    FILM-COATED
    IBUPROFEN
    SODIUM

    Advil®

    menstrual
    PAIN

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

    Tablets

    40 Tablets

    PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL MENSTRUAL PAIN 
    ibuprofen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM256 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE (UNII: D9C330MD8B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (beige) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code Advil;msp
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0230-201 in 1 CARTON07/01/2016
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0230-401 in 1 CARTON07/01/2016
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20180306/30/2016
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0230) , LABEL(0573-0230) , MANUFACTURE(0573-0230) , PACK(0573-0230)