MIGRAIDE- cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet 
Schwabe Mexico, S.A. de C.V.

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 Tablets

Active Ingredient

Cimicifuga racemosa 3X

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

Inactive

Cellulose

Lactose Monohydrate
Magnesium Stearate

Dosage & Administration

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 to 12: Take 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved.
Children under 2: 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.

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.

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.

Pregnacy or Breast Feeding

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

Keep out of reach of chiildren.

Keep out of reach of chiildren.

Overdose

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

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MIGRAIDE 
cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-2391
Route of AdministrationSUBLINGUAL, SUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER3 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]
IRIS VERSICOLOR WHOLE (UNII: PYC571247P) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR WHOLE2 [hp_X]
GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE3 [hp_X]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (B;T) Scoreno score
ShapeROUND (B;T) Size8mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68466-2391-44 in 1 BOX07/02/201512/31/2025
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/02/201512/31/2026
Labeler - Schwabe Mexico, S.A. de C.V. (812805901)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-2391)

Revised: 11/2021
Document Id: 6ef6d2c9-91ab-4182-a27f-3ca487f06c4f
Set id: 908816fc-2ef3-4120-8e6f-54e8bb1e39ae
Version: 6
Effective Time: 20211109
 
Schwabe Mexico, S.A. de C.V.