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]

Active Ingredient

Cimicifuga racemosa 3X

Cyclamen europaeum 3X 

Gelsemium sempervirens 3X
Iris versicolor 4X
Sanguinaria canadensis 3X

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 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

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.

PRINCIPAL DISPLAY PANEL

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: 53499-3391
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	4 [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: 53499-3391-1	4 in 1 BOX	11/09/2021	01/31/2027
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		11/09/2021	01/31/2027

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-3391)