Label: HYPERCALM - MENTAL FOCUS- adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla, coffea cruda, cypripedium, digitalis, gelsemium, humulus, hyoscyamus, ignatia, impatiens glandulifera flos, iodium, lachesis, lycopodium, nat. mur., nux vom., scutellaria lateriflora, staphysag., stramonium, theridion, veratrum viride, echinacea, hypericum, passiflora 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 March 1, 2011

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  • INDICATIONS & USAGE SECTION

    Hypercalm - Mental Focus  Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

  • DOSAGE & ADMINISTRATION SECTION

    ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Adrenalinum 15x, Tarentula cubensis 15x, Aconitum nap. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Chamomilla 10x, Coffea cruda 10x, Cypripedium 10x, Digitalis 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Impatiens glandulifera flos 10x, Iodium 10x, Lachesis 10x, Lycopodium 10x, Nat. mur. 10x, Nux vom. 10x, Scutellaria lateriflora 10x, Staphysag. 10x, Stramonium 10x, Theridion 10x, Veratrum viride 10x, Chamomilla 3x, Echinacea 3x, Hypericum 3x, Passiflora 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
    Questions?  1.800.448.7256 

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    HYPERCALM - MENTAL FOCUS  
    adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla, coffea cruda, cypripedium, digitalis, gelsemium, humulus, hyoscyamus, ignatia, impatiens glandulifera flos, iodium, lachesis, lycopodium, nat. mur., nux vom., scutellaria lateriflora, staphysag., stramonium, theridion, veratrum viride, echinacea, hypericum, passiflora liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1514
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine15 [hp_X]  in 1 mL
    Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823) Citharacanthus Spinicrus15 [hp_X]  in 1 mL
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus10 [hp_X]  in 1 mL
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate10 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
    Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria10 [hp_X]  in 1 mL
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita10 [hp_X]  in 1 mL
    Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean10 [hp_X]  in 1 mL
    Cypripedium Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA) Cypripedium Parvifolum Root10 [hp_X]  in 1 mL
    Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis10 [hp_X]  in 1 mL
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root10 [hp_X]  in 1 mL
    Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops10 [hp_X]  in 1 mL
    Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger10 [hp_X]  in 1 mL
    Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed10 [hp_X]  in 1 mL
    Impatiens Glandulifera Flower (UNII: AJU5O1A5ZV) (Impatiens Glandulifera Flower - UNII:AJU5O1A5ZV) Impatiens Glandulifera Flower10 [hp_X]  in 1 mL
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine10 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride10 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
    Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC) Scutellaria Lateriflora10 [hp_X]  in 1 mL
    Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed10 [hp_X]  in 1 mL
    Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium10 [hp_X]  in 1 mL
    Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum10 [hp_X]  in 1 mL
    Veratrum Viride Root (UNII: 197B3Q7T5Q) (Veratrum Viride Root - UNII:197B3Q7T5Q) Veratrum Viride Root10 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum3 [hp_X]  in 1 mL
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1514-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-1514-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-1514-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-1514)
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