FDA Label for Migralex Dr. Mauskop
View Indications, Usage & Precautions
Migralex Dr. Mauskop Product Label
The following document was submitted to the FDA by the labeler of this product Migralex Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- 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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