Label: ADVIL MENSTRUAL PAIN- ibuprofen sodium tablet, coated

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

Drug Label Information

Updated September 1, 2021

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

  • Active ingredient (in each tablet)

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

    *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 at 20 weeks or later in 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

  • Additional Information

    Do Not Use if seal under bottle cap imprinted with

    “SEALED for YOUR PROTECTION” is broken or missing.

    READ AND KEEP CARTON FOR COMPLETE

    WARNINGS AND INFORMATION

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

    Dist. by: GSK CH, Warren, NJ 07059 ©2021 GSK or licensor

    Trademarks owned or licensed by GSK Patents: www.productpats.com

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0230-20

    Advil

    menstrual
    PAIN

    FILM-COATED
    IBUPROFEN
    SODIUM

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

    Advil Tablets

    20 Tablets

    000068432 Front Carton

    Advil Menstrual Tablets 20 ct
  • 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 K25-31 (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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0230) , LABEL(0573-0230) , MANUFACTURE(0573-0230) , PACK(0573-0230)