Label: MIGRAIDE- cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet
- NDC Code(s): 53499-3391-1
- Packager: Schwabe North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 24, 2022
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- Active Ingredient
- Inactive Ingredient
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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
- Indications & Usage
- Warings
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIGRAIDE
cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tabletProduct 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)
