Label: SYNAPTOL LACTOSE FREE- aconitum ferox, adrenalinum, aesculus hippocastanum, flos, apis mellifica, argentum nitricum, avena sativa, baptisia tinctoria, cochlearia armoracia, phosphorus, scleranthus annuus, flos, scutellaria lateriflora, sumbul, viola odorata tablet, orally disintegrating

  • 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 October 20, 2023

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  • ACTIVE *HPUS INGREDIENTS:

    Aconitum Ferox 10X, 30X, 100X, Adrenalinum 10X, 30X, 100X, Aesculus Hippocastanum, Flos 10X, 30X, 100X, Apis Mellifica 10X, 30X, 100X, Argentum Nitricum 10X, 30X, 100X, Avena Sativa 10X, 30X, 100X, Baptisia Tinctoria 10X, 30X, 100X, Cochlearia Armoracia 10X, 30X, 100X, Phosphorus 10X, 30X, 100X, Scleranthus Annuus, Flos 10X, 30X, 100X, Scutellaria Lateriflora 10X, 30X, 100X, Sumbul 10X, 30X, 100X, Viola Odorata 10X, 30X, 100X
    Each active ingredient contains equal volumes of 10X, 30X, and 100X potencies.
    *The letters ‘HPUS’ indicated that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • USES:

    for the temporary relief of hyperactivity & inattention symptoms including:

    •poor focus

    •impulsivity

    •fidgeting

    •difficulty concentrating when reading or writing

    Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

  • STORAGE & HANDLING:

    Do not store next to electrical devices or appliances.

    Keep lid tightly closed & store in a cool, dry place.

  • WARNINGS:

    Stop use and as a doctor ifsymptoms persist or worsen.

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

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

    Do not use if tamper seal is broken.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    30 sec. under tongue, then swallow with water.

    30-50lb (13.6kg-22.6kg): 1/2 tablet twice daily.

    50lb+ (22.6kg): 1 tablet twice daily.

  • INDICATIONS:

    for the temporary relief of hyperactivity & inattention symptoms including:

    •poor focus

    •impulsivity

    •fidgeting

    •difficulty concentrating when reading or writing

    Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

  • INACTIVE INGREDIENTS:

    Magnesium Stearate, Microcrystalline Cellulose, Sucrose

  • QUESTIONS:

    Distributed By:

    HelloLife, Inc.

    4655 Patterson Ave SE, Ste. C

    Grand Rapids, MI 49512

    www.hellolife.net

  • PACKAGE LABEL DISPLAY:

    Synaptol Lactose Free

    NDC 49726-048-60

    Synaptol Lactose Free Tablets

    Natural Hyperactivity &

    Inattention Symptom Relief

    Homeopathic (OTC) Medicine

    60 Dissolving Tablets

  • INGREDIENTS AND APPEARANCE
    SYNAPTOL LACTOSE FREE 
    aconitum ferox, adrenalinum, aesculus hippocastanum, flos, apis mellifica, argentum nitricum, avena sativa, baptisia tinctoria, cochlearia armoracia, phosphorus, scleranthus annuus, flos, scutellaria lateriflora, sumbul, viola odorata tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM FEROX ROOT (UNII: I4G31A93ZR) (ACONITUM FEROX ROOT - UNII:I4G31A93ZR) ACONITUM FEROX ROOT10 [hp_X]
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE10 [hp_X]
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH10 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]
    SCLERANTHUS ANNUUS FLOWERING TOP (UNII: CC4B5WU2XX) (SCLERANTHUS ANNUUS FLOWERING TOP - UNII:CC4B5WU2XX) SCLERANTHUS ANNUUS FLOWERING TOP10 [hp_X]
    SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA WHOLE10 [hp_X]
    FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT10 [hp_X]
    VIOLA ODORATA WHOLE (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA WHOLE10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49726-048-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/27/2022
    Labeler - HelloLife, Inc. (065619378)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(49726-048) , api manufacture(49726-048) , label(49726-048) , pack(49726-048)
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