Label: MIGRALEX DR. MAUSKOP- aspirin buffered with magnesium oxide tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 23, 2009

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  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)

    Aspirin 500 mg (Purpose: Pain Reliever)

    Buffered with Magnesium Oxide 75 mg
  • PURPOSE

    Uses

    for the temporary relief of minor aches and pain associated with:

    • Tension Headaches
    • Sinus Headaches
    • Stress Headaches
    • Chronic Headaches
    • Menstrual Headaches
  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include hives, asthma (wheezing), facial swelling, shock, rash, skin reddening, and blisters.

    Alcohol warning: If you consume 3 or more alcoholic drinks everyday, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

  • DO NOT USE

    Do not use

    if you are allergic to aspirin or any other pain reliever/fever reducer

  • ASK DOCTOR

    Ask a doctor before use if you have

    • kidney disease   
    • asthma
    • a magnesium-restricted diet
    • bleeding problems
    • stomach problems that last or come back (such as heartburn, upset stomach or stomach pain), or if you have ulcers.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • anticoagulation (thinning the blood)
    • gout
    • diabetes
    • arthritis
  • STOP USE

    Stop use and ask a doctor if

    • allergic reaction occurs. Seek medical help right away.
    • pain gets worse or lasts for more than 10 days
    • new symptoms occur
    • fever gets worse or lasts for more than 3 days
    • ringing in the ears or a loss of hearing occurs
    • redness or swelling is present
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use. It is especially important not to use aspirin 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • STORAGE AND HANDLING

    Directions

    • Drink a full glass of water with each dose
    • Adults and children 12 years and over: take 2 tablets every 6 hours while symptoms persist, but not more than 8 tablets in 24 hours, or as directed by a doctor
    • Children under 12 years: ask a doctor
    Other Information

    • store at room temperature
    • read all product information before using
    • save carton for full directions and warnings
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Fractionated coconut oil, Hypromellose, Maltodextrin, Microcrystalline cellulose, Polydextrose, Sodium starch glycolate, Stearic acid, Talc, Titanium dioxide.

  • QUESTIONS

    Questions or comments: 1 877 - 466 - 0294.

    Distributed by Migralex Inc. Larchmont, New York 10538   Made in Canada   U.S. Patent #5538959, 5914129

    TAMPER EVIDENT BOTTLE.

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    image of carton label

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    MIGRALEX  DR. MAUSKOP
    aspirin buffered with magnesium oxide tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49886-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin500 mg
    magnesium oxide (UNII: 3A3U0GI71G) (magnesium oxide - UNII:3A3U0GI71G) magnesium oxide75 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49886-001-0120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2009
    Labeler - Migralex Inc. (009883785)
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