FDA.reportPublic FDA data

Migraide Tablets

Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.
Effective date
2022-03-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:17:13

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 4X
Sanguinaria canadensis 3X

Inactive Ingredient 

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 30 minutes after eating, brushing teeth, or drinking anything except water.

Adults and Children 12 years 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: 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

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.

Warings

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.

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

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.

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use this product if you are pregnant or breast-feeding.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBN21812390.B01 Z Migraide 40 tabs.jpgLBN21812390.B01 Z Migraide 40 tabs.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3391-1Migraide4 in 1 BOXtablet42
53499-3391-1Migraide10 in 1 BLISTER PACKtablet102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20220405_0dc575dd-ef7e-4f91-a2b3-0ea3637a871e.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
53499-339153499-3391-1

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 North America, Inc.0dc575dd-ef7e-4f91-a2b3-0ea3637a871e2022-03-24WarningsExact identifier
ndc (package): 53499-3391-1
ndc (product): 53499-3391
ndc11 (package): 53499339101
spl id: bc629508-09ed-4ceb-b954-9dbc2c2d07ab
spl set id: 0dc575dd-ef7e-4f91-a2b3-0ea3637a871e

Reported adverse events (FAERS/openFDA)#

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