Label: HEADACHE - MIGRAINE- elaps corallinus, arsenicum alb., belladonna, bryonia, carduus benedictus, cimicifuga, coffea cruda, convallaria, crotalus horridus, digitalis, gelsemium, glonoinum, ignatia, lachesis, merc. viv., naja, nux vom., phosphorus, rhus toxicodendron, sanguinaria, secale, vipera berus, apis mel., hypericum, thuja occ. pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4445-1, 55714-4445-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION 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 June 1, 2011
If you are a consumer or patient please visit this version.
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Elaps corallinus 30x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.
- PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
HEADACHE - MIGRAINE
elaps corallinus, arsenicum alb., belladonna, bryonia, carduus benedictus, cimicifuga, coffea cruda, convallaria, crotalus horridus, digitalis, gelsemium, glonoinum, ignatia, lachesis, merc. viv., naja, nux vom., phosphorus, rhus toxicodendron, sanguinaria, secale, vipera berus, apis mel., hypericum, thuja occ. pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4445 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom 30 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 g Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 g Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta 15 [hp_X] in 1 g Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 15 [hp_X] in 1 g Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 15 [hp_X] in 1 g Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis 15 [hp_X] in 1 g Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom 15 [hp_X] in 1 g Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis 15 [hp_X] in 1 g Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 g Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin 15 [hp_X] in 1 g Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 15 [hp_X] in 1 g Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 g Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 15 [hp_X] in 1 g Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom 15 [hp_X] in 1 g Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 15 [hp_X] in 1 g Sanguinaria Canadensis Root (UNII: N9288CD508) (Sanguinaria Canadensis Root - UNII:N9288CD508) Sanguinaria Canadensis Root 15 [hp_X] in 1 g Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium 15 [hp_X] in 1 g Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom 15 [hp_X] in 1 g Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 3 [hp_X] in 1 g Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 3 [hp_X] in 1 g Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4445-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-4445-2 56.7 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4445)
