MIGRAIDE- cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet

Migraide by

Drug Labeling and Warnings

Migraide by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

Lactose Monohydrate
Magnesium Stearate
Cellulose

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 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved.
Children under 6: Consult a doctor.

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

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 and ask a doctor if pain persists or gets worse or if new symptoms occur.

These could be signs of a serious condition.

OTC - ASK DOCTOR 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 and ask a doctor if pain persists or gets worse or if new symptoms occur.
These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANELBoericke and Tafel Migraide  21812390  40 tablets 

INGREDIENTS AND APPEARANCE

MIGRAIDE 
cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-2391
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q)	CYCLAMEN PURPURASCENS TUBER	3 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X]
IRIS VERSICOLOR WHOLE (UNII: PYC571247P) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR WHOLE	2 [hp_X]
GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K)	GELSEMIUM SEMPERVIRENS WHOLE	3 [hp_X]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (B;T)	Score	no score
Shape	ROUND (B;T)	Size	8mm
Flavor		Imprint Code	B;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2391-1	4 in 1 BOX	07/02/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/02/2015

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-2391)