FDA.reportPublic FDA data

Migraide Tablets

Manufacturer
Schwabe Mexico, S.A. de C.V.
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:15:08

Label at a glance#

ProductMigraide
Active ingredientCYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cimicifuga racemosa 3X

Cyclamen europaeum 3X 
Gelsemium sempervirens 3X
Iris versicolor 2X
Sanguinaria canadensis 3X

Inactive

INACTIVE INGREDIENT SECTION

Cellulose

Lactose Monohydrate
Magnesium Stearate

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Sublingual homeopathic medication.
Place tablets under tongue at least 15 minutes before or half hour 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 to 12: Take 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved.
Children under 2: Consult a doctor.

Purpose

OTC - PURPOSE SECTION

For the temporary relief of minor aches and pains associated with headaches or migraine headaches.

Indications & Usage

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with headaches or migraine headaches.

Warnings

WARNINGS SECTION

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.

Stop Use

OTC - STOP USE SECTION

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.

Pregnacy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of chiildren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of chiildren.

Overdose

OVERDOSAGE SECTION

In case of overdose, seek medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

21812390_Migraide_A02.jpg21812390_Migraide_A02.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68466-2391-4Migraide10 in 1 BLISTER PACKTABLET106
68466-2391-4Migraide4 in 1 BOXTABLET46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-2391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE MEXICO, S.A. DE C.V.]6Current NDC, Legacy NDC, 2 package rows20211111_908816fc-2ef3-4120-8e6f-54e8bb1e39ae.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68466-239168466-2391-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
BLACK COHOSHK73E24S6X9ACTIB
IRIS VERSICOLOR WHOLEPYC571247PACTIB
GELSEMIUM SEMPERVIRENS WHOLER0519OZO3KACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
MigraideCYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOTSchwabe Mexico, S.A. de C.V.908816fc-2ef3-4120-8e6f-54e8bb1e39ae2021-11-09WarningsExact identifier
ndc (package): 68466-2391-4
ndc (product): 68466-2391
ndc11 (package): 68466239104
spl id: 6ef6d2c9-91ab-4182-a27f-3ca487f06c4f
spl set id: 908816fc-2ef3-4120-8e6f-54e8bb1e39ae

Reported adverse events (FAERS/openFDA)#

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