Migralex
FDA Label NDC 49886-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Migralex Inc. for the product Migralex (NDC 49886-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each tablet)Aspirin 500 mg (Purpose: Pain Reliever)Buffered with Magnesium Oxide 75 mg

Otc - Purpose

Uses

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

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

Warnings

WarningsReye'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.

Otc - Do Not Use

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

Otc - 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.

Otc - 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

Otc - 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

Otc - 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.

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

Otc - 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

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