Label: SEDALIA- aconitum napellus, belladonna leaf, calendula officinalis flowering top, chelidonium majus, abrus precatorius seed, viburnum opulus root tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 0220-9332-04 - Packager: Laboratoires Boiron
- 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 May 2, 2018
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- ACTIVE INGREDIENT
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PURPOSE
Aconitum napellus 6C Relieves restlessness, agitation
Belladona 6C Relieves hypersensitivity to stress
Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise
Chelidonium majus 6C Relieves digestive symptoms caused by stress
Jequirity 6C Relieves uneasiness
Viburnum opulus 6C Relieves nervousness and restless sleep - INDICATIONS & USAGE
- STOP USE
- ASK DOCTOR
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DESCRIPTION
- STORAGE AND HANDLING
- DRUG INTERACTIONS
- INACTIVE INGREDIENT
- QUESTIONS
- HOW SUPPLIED
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEDALIA
aconitum napellus, belladonna leaf, calendula officinalis flowering top, chelidonium majus, abrus precatorius seed, viburnum opulus root tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9332 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_C] BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF 6 [hp_C] CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_C] CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 6 [hp_C] ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED 6 [hp_C] VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK 6 [hp_C] Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND (BOIRON) Size 9mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9332-04 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/05/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/05/1997 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9332)