Label: CEREBRAL COMPOSITION (cholinum, capsicum annuum, ginkgo biloba, arnica montana, gelsemium sempervirens, kali phosphoricum, anacardium orientale, phosphorus, serotonin- hydrochloride, baryta carbonica 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 16, 2014

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  • ACTIVE INGREDIENTS:

    Cholinum 2X, 3X, Capsicum Annuum 3X, Ginkgo Biloba 3X, Arnica Montana 3X, 6X, Gelsemium Sempervirens 3X, 6X, Kali Phosphoricum 3X, 6X, Anacardium Orientale 6X, 12X, Phosphorus 6X, 12X, Serotonin (Hydrochloride) 6X, 12X, Baryta Carbonica 8X, 12X

  • INDICATIONS:

    For temporary relief of general tiredness, drowsiness, dullness, weak memory, and confusion.

  • WARNINGS:

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

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

    Do not use if tamper seal is broken or missing.

  • 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 general tiredness, drowsiness, dullness, weak memory, and confusion.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC

    251 West Road

    Campobello, SC 29322

  • PACKAGE LABEL DISPLAY:

    Synergy Formulas

    CEREBRAL COMPOSITION

    HOMEOPATHIC

    2 FL OZ (60 ml)

    CEREBRAL COMPOSITION

  • INGREDIENTS AND APPEARANCE
    CEREBRAL COMPOSITION 
    cholinum, capsicum annuum, ginkgo biloba, arnica montana, gelsemium sempervirens, kali phosphoricum, anacardium orientale, phosphorus, serotonin (hydrochloride, baryta carbonica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLINE HYDROXIDE (UNII: 7THJ3EG9SY) (CHOLINE - UNII:N91BDP6H0X) CHOLINE HYDROXIDE2 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO3 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]  in 1 mL
    ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 1 mL
    SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE6 [hp_X]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0036-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/16/2014
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0036) , api manufacture(43772-0036) , label(43772-0036) , pack(43772-0036)
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