Migraide

Drug Labeling and Warnings

Drug Details [pdf]

MIGRAIDE- cyclamen purpurascens tuber, black cohosh, gelsemium sempervirens root, iris versicolor root, sanguinaria canadensis root tablet 
Schwabe North America, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Migraide

ACTIVE INGREDIENTS (HPUS):

Cyclamen europaeum 3X

Cimicurfuga racemosa 3X

Gelsemium sempervirens 3X

Iris versicolor 2X

Sanguinaria canadensis 2X

Inactive Ingredients:

Lactose

Magnesium Stearate

Microcystalline cellulose

Dosage and Administration:

Directions: Sublingual 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: 3 tablets every hour until symptoms subside, then every 2 hours until relieved.

Children 2 to 12: Half of the adult dose.

Children under 2: Consult a doctor.

Indication and Usage:

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

Warnings:
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.

If pain persists or gets worse or if new symptoms occur, consult a doctor because these could be signs of a serious condition.

Pregnancy and Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

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.

If pain persists or gets worse or if new symptoms occur, consult a doctor because these could be signs of a serious condition.

Overdosage:

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

Purpose:

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

Migraide Carton:
21812390_02-Migraide

21812390_02-Migraide.jpg

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-2390
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]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	3 [hp_X]
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	2 [hp_X]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2390-1	1 in 1 BOX	08/18/2011	05/31/2019
1		40 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		08/18/2011	05/31/2019

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-2390)

Revised: 2/2017

Document Id: 8347946f-c5ed-42b5-a487-e7fc3ab04502

Set id: 59f6f090-2803-4363-8f91-57aeff559011

Version: 4

Effective Time: 20170223