Migralex

Manufacturer
Migralex Inc.
Effective date
2009-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:45

Label at a glance#

ProductMigralex Dr. Mauskop
Active ingredientaspirin, magnesium oxide
Label structure13 sections

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Aspirin 500 mg (Purpose: Pain Reliever)

Buffered with Magnesium Oxide 75 mg

OTC - PURPOSE SECTION

Uses

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

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

STORAGE AND HANDLING SECTION

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 SECTION

Inactive Ingredients

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

OTC - QUESTIONS SECTION

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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton label
image of carton label

image of bottle label
image of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198471aspirin 500 MG Oral TabletPSN1
1039499Migralex 500 MG Oral TabletPSN1
1039499aspirin 500 MG Oral Tablet [Migralex]SBD1
198471aspirin 500 MG Oral TabletSCD1
198471ASA 500 MG Oral TabletSY1
1039499ASA 500 MG Oral Tablet [Migralex]SY1
1039499Migralex 500 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49886-001-012019-10-21C16284748780-1956f9ecf-d0e9-621f-e053-dbdaa90a74adMigralex Labeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49886-001-01MigralexDr. Mauskop20 in 1 BOTTLE, PLASTICTABLET, COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49886-001MIGRALEX DR. MAUSKOP (ASPIRIN BUFFERED WITH MAGNESIUM OXIDE) TABLET, COATED [MIGRALEX INC.]1Legacy NDC, 1 package rows20091115_31962eb9-690c-4727-852d-d6dfbf842c2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76E1
magnesium oxideACTIVE INGREDIENT3A3U0GI71G1
aspirinACTIVE MOIETYR16CO5Y76E1
magnesium oxideACTIVE MOIETY3A3U0GI71G1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49886-00149886-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
aspirinR16CO5Y76EACTIB
magnesium oxide3A3U0GI71GACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0be179e8-6b58-424d-8af2-be237a80bc8431962eb9-690c-4727-852d-d6dfbf842c2a2009-10-23WarningsExact identifier
spl id: 0be179e8-6b58-424d-8af2-be237a80bc84
spl set id: 31962eb9-690c-4727-852d-d6dfbf842c2a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.