NDC | 55714-1514-0, 55714-1514-1, 55714-1514-2 |
Set ID | 9727cc48-3103-2655-369a-cc745d0509af |
Category | HUMAN OTC DRUG LABEL |
Packager | Newton Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1514 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine 15 [hp_X] in 1 mL Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823) Citharacanthus Spinicrus 15 [hp_X] in 1 mL Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 10 [hp_X] in 1 mL Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 10 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 mL Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria 10 [hp_X] in 1 mL Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 10 [hp_X] in 1 mL Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 10 [hp_X] in 1 mL Cypripedium Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA) Cypripedium Parvifolum Root 10 [hp_X] in 1 mL Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis 10 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 10 [hp_X] in 1 mL Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops 10 [hp_X] in 1 mL Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger 10 [hp_X] in 1 mL Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 10 [hp_X] in 1 mL Impatiens Glandulifera Flower (UNII: AJU5O1A5ZV) (Impatiens Glandulifera Flower - UNII:AJU5O1A5ZV) Impatiens Glandulifera Flower 10 [hp_X] in 1 mL Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 10 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 10 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 10 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 10 [hp_X] in 1 mL Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC) Scutellaria Lateriflora 10 [hp_X] in 1 mL Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed 10 [hp_X] in 1 mL Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 10 [hp_X] in 1 mL Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum 10 [hp_X] in 1 mL Veratrum Viride Root (UNII: 197B3Q7T5Q) (Veratrum Viride Root - UNII:197B3Q7T5Q) Veratrum Viride Root 10 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 mL Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 3 [hp_X] in 1 mL Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1514-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-1514-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-1514-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-1514)