Label: HEADACHE (melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia- alba, cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis liquid

  • 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 July 14, 2021

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  • ACTIVE INGREDIENTS:

    Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.

  • INDICATIONS:

    For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

  • WARNINGS:

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    HEADACHE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Headache

  • INGREDIENTS AND APPEARANCE
    HEADACHE 
    melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP3 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH12 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    CITHARACANTHUS SPINICRUS (UNII: 3Y5X6RT823) (CITHARACANTHUS SPINICRUS - UNII:3Y5X6RT823) CITHARACANTHUS SPINICRUS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0488-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/19/2018
    Labeler - BioActive Nutritionals, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0488) , api manufacture(43857-0488) , label(43857-0488) , pack(43857-0488)
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