MIGRALEX DR. MAUSKOP- aspirin buffered with magnesium oxide tablet, coated 
Migralex Inc.

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.

----------

Migralex Labeling

Active Ingredients (in each tablet)

Aspirin 500 mg (Purpose: Pain Reliever)

Buffered with Magnesium Oxide 75 mg

Uses

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

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

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

Ask a doctor before use if you have

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

Stop use and ask a doctor if

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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

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

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


image of carton label

image of bottle label

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)

Revised: 10/2009
Document Id: 0be179e8-6b58-424d-8af2-be237a80bc84
Set id: 31962eb9-690c-4727-852d-d6dfbf842c2a
Version: 1
Effective Time: 20091023
 
Migralex Inc.