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.
Updated October 23, 2009
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- ACTIVE INGREDIENT
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
STORAGE AND HANDLING
- 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MIGRALEX DR. MAUSKOP
aspirin buffered with magnesium oxide tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49886-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin 500 mg magnesium oxide (UNII: 3A3U0GI71G) (magnesium oxide - UNII:3A3U0GI71G) magnesium oxide 75 mg Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49886-001-01 20 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/15/2009 Labeler - Migralex Inc. (009883785)