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 
Newton Laboratories, Inc.

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.

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Headache - Migraine

INDICATIONS & USAGE SECTION

HEADACHE - MIGRAINE      Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.         

DOSAGE & ADMINISTRATION SECTION             

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.         

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

Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets. 

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
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.            

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.       

PACKAGE LABEL

package 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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4445
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom30 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 g
Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta15 [hp_X]  in 1 g
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 g
Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean15 [hp_X]  in 1 g
Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis15 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom15 [hp_X]  in 1 g
Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 g
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin15 [hp_X]  in 1 g
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed15 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury15 [hp_X]  in 1 g
Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom15 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 g
Sanguinaria Canadensis Root (UNII: N9288CD508) (Sanguinaria Canadensis Root - UNII:N9288CD508) Sanguinaria Canadensis Root15 [hp_X]  in 1 g
Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium15 [hp_X]  in 1 g
Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom15 [hp_X]  in 1 g
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum3 [hp_X]  in 1 g
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4445-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-4445-256.7 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4445)

Revised: 6/2011
Document Id: ce552a8e-4374-10a3-c8ac-c725fa9c6fa2
Set id: af25d44a-3ef1-43e5-ec41-121dcb484c5a
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.