Otc - Active Ingredient
Active ingredients (in each tablet): Acetaminophen -500 mg, (Pain reliever),
Caffeine -65 mg (Pain reliever aid).
Migrenol
FDA Label NDC 69293-565
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Four Ventures Enterprises, Inc. for the product Migrenol (NDC 69293-565). 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, indications & usage, warnings, dosage & administration, otc - pregnancy or breast feeding, otc - keep out of reach of children, package label.principal display panel, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
temporary relief of occasional headaches and minor aches and pains due to
headache, muscular aches,
toothache, premenstrual and menstrual cramps
Warnings
DO NOT USE:
- with any other product containing acetaminophen
- if you ever had an allergic reaction to any other pain reliever/fever reducer.
ASK DOCTOR BEFORE USE if you have liver desease.
ASK A DOCTOR OR PHARMACIST BEFORE USE if you are taking sedatives or tranquilizers when using this product
- drowsiness will occur
- avoid alcoholic drinks
STOP USE AND ASK A DOCTOR IF
- an allergic reaction occurs. Seek medical help right away.
-new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
LIVER WARNING: This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 8 tables in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.
Dosage & Administration
- do not take more than directed
Adults and children 12 years and over:
- take 2 tablets every 6 hours
- do not take more than 8 tablets in 24 hours
Children under 12 years: do not use this adult product in children under 12 years of age: this will provide more than the recommended dose
and may cause liver damage.
Otc - Pregnancy Or Breast Feeding
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
Mm2
Migrenol Englisj 16 (Migrenolenglish16tablets)
Inactive Ingredient
INACTIVE INGREDIENTS: Croscarmellose Sodium, Dicalcium,
Phosphate, Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene glycol, Povidone, Silica,
Sodium Starch Glycolate, Starch, Stearic Acid.
Otc - Purpose
Pupose: Pain reliever, Fever Reducer
* Please review the disclaimer below.
