MENOPAUSE - elaps corallinus, agnus, angelica sinensis radix, arsenicum alb., bryonia, cantharis, caulophyllum, cimicifuga, cinchona, crotalus horridus, damiana, glonoinum, helonias dioica, ignatia, kali carb., lachesis, naja, nux vom., phosphorus, pulsatilla, salix nigra, sanguinaria, sepia, echinacea, valeriana 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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Menopause

INDICATIONS & USAGE SECTION

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

DOSAGE & ADMINISTRATION SECTION

Directions:  Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

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. 

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

MENOPAUSE  
elaps corallinus, agnus, angelica sinensis radix, arsenicum alb., bryonia, cantharis, caulophyllum, cimicifuga, cinchona, crotalus horridus, damiana, glonoinum, helonias dioica, ignatia, kali carb., lachesis, naja, nux vom., phosphorus, pulsatilla, salix nigra, sanguinaria, sepia, echinacea, valeriana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2235
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
Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A) Chaste Tree10 [hp_X]  in 1 g
Angelica Sinensis Root (UNII: B66F4574UG) (Angelica Sinensis Root - UNII:B66F4574UG) Angelica Sinensis Root10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria10 [hp_X]  in 1 g
Caulophyllum Thalictroides Root (UNII: JTJ6HH6YEH) (Caulophyllum Thalictroides Root - UNII:JTJ6HH6YEH) Caulophyllum Thalictroides Root10 [hp_X]  in 1 g
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh10 [hp_X]  in 1 g
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom10 [hp_X]  in 1 g
Turnera Diffusa Leafy Twig (UNII: RQ2CFA7WWJ) (Turnera Diffusa Leafy Twig - UNII:RQ2CFA7WWJ) Turnera Diffusa Leafy Twig10 [hp_X]  in 1 g
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin10 [hp_X]  in 1 g
Chamaelirium Luteum Root (UNII: DQV54Y5H3U) (Chamaelirium Luteum Root - UNII:DQV54Y5H3U) Chamaelirium Luteum Root10 [hp_X]  in 1 g
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed10 [hp_X]  in 1 g
Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate10 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 g
Salix Nigra Bark (UNII: QU52J3A5B3) (Salix Nigra Bark - UNII:QU52J3A5B3) Salix Nigra Bark10 [hp_X]  in 1 g
Sanguinaria Canadensis Root (UNII: N9288CD508) (Sanguinaria Canadensis Root - UNII:N9288CD508) Sanguinaria Canadensis Root10 [hp_X]  in 1 g
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice10 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2235-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-2235-256.7 g in 1 BOTTLE, GLASS
3NDC:55714-2235-07.08 g 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(55714-2235)

Revised: 3/2011
Document Id: f26cd39b-1c0a-f6cd-1250-169ab3e7654f
Set id: 9f04d505-7475-ef8a-57ab-eb820fb49726
Version: 2
Effective Time: 20110301
 
Newton Laboratories, Inc.