Active Ingredient
Cimicifuga racemosa 3X
Cyclamen europaeum 3X
Gelsemium sempervirens 3X
Iris versicolor 4X
Sanguinaria canadensis 3X
Migraide Tablet
FDA Label NDC 53499-3391
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Migraide (NDC 53499-3391). 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 active ingredient, inactive ingredient, dosage & administration, purpose, indications & usage, warings, stop use, pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Cellulose
Lactose Monohydrate
Magnesium Stearate
Dosage & Administration
Directions: Sublingual homeopathic medication.
Place tablets under tongue at least 15 minutes before or 30 minutes after eating, brushing teeth, or drinking anything except water.
Adults and Children 12 years of age and older: Take 3 tablets every hour until symptoms subside, then take 3 tablets every 2 hours until relieved.
Children 6-12 years of age and older: Take 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved.
Children under 6 years of age: Consult a doctor.
Purpose
For the temporary relief of minor aches and pains associated with headaches or migraine headaches.
Indications & Usage
For the temporary relief of minor aches and pains associated with headaches or migraine headaches.
Warings
Do not take this product for headache pain for more than 10 days (for adults) or 5 days (for children) unless directed by a doctor.
Do not use if hypersensitive to any other ingredients in this product.
Do not use this product if you are pregnant or breast-feeding.
Stop Use
Stop use and ask a doctor if pain persists or gets worse or if new symptoms occur.
These could be signs of a serious condition.
Pregnancy Or Breast Feeding
Do not use this product if you are pregnant or breast-feeding.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdose
In case of overdose, seek medical help or contact a Poison Control Center immediately.
* Please review the disclaimer below.
