Migraide Tablets

Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:28:28

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 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 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 6-12 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

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.

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

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

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

21812390_Migraide_A02.jpg21812390_Migraide_A02.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-2391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.]6Legacy NDC20211111_d93e48c9-94d6-4d60-8245-cd1ee9f54816.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
53499-239153499-2391-1

Ingredients#

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

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

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
7b67343b-d693-4cbd-964e-4d673a401a3ed93e48c9-94d6-4d60-8245-cd1ee9f548162021-11-09WarningsExact identifier
spl id: 7b67343b-d693-4cbd-964e-4d673a401a3e
spl set id: d93e48c9-94d6-4d60-8245-cd1ee9f54816

Reported adverse events (FAERS/openFDA)#

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