Menopause

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:05:00

Label at a glance#

ProductMenopause
Active ingredientMicrurus Corallinus Venom, Chaste Tree, Angelica Sinensis Root, Arsenic Trioxide, Bryonia Alba Root, Lytta Vesicatoria, Caulophyllum Thalictroides Root, Black Cohosh, Cinchona Officinalis Bark, Crotalus Horridus Horridus Venom, Turnera Diffusa Leafy Twig, Nitroglycerin, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Potassium Carbonate, Lachesis Muta Venom, Naja Naja Venom, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Salix Nigra Bark, Sanguinaria Canadensis Root, Sepia Officinalis Juice, Echinacea, Unspecified, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

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

OTC - 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.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2235-02020-01-31C16284748780-19d75b9d0-5737-f424-e053-dadaa90a57ceMenopause
55714-2235-12020-01-31C16284748780-19d75b9d0-5737-f424-e053-dadaa90a57ceMenopause
55714-2235-22020-01-31C16284748780-19d75b9d0-5737-f424-e053-dadaa90a57ceMenopause

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2235-0Menopause7.08 g in 1 BOTTLE, GLASSPELLET7.082
55714-2235-1Menopause28.35 g in 1 BOTTLE, GLASSPELLET28.352
55714-2235-2Menopause56.7 g in 1 BOTTLE, GLASSPELLET56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2235MENOPAUSE (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.]2Legacy NDC, 3 package rows20131015_9f04d505-7475-ef8a-57ab-eb820fb49726.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Angelica Sinensis RootACTIVE INGREDIENTB66F4574UG2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Black CohoshACTIVE INGREDIENTK73E24S6X92
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Caulophyllum Thalictroides RootACTIVE INGREDIENTJTJ6HH6YEH2
Chamaelirium Luteum RootACTIVE INGREDIENTDQV54Y5H3U2
Chaste TreeACTIVE INGREDIENT433OSF3U8A2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9562
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369802
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM2
NitroglycerinACTIVE INGREDIENTG59M7S0WS32
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Salix Nigra BarkACTIVE INGREDIENTQU52J3A5B32
Sanguinaria Canadensis RootACTIVE INGREDIENTN9288CD5082
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Turnera Diffusa Leafy TwigACTIVE INGREDIENTRQ2CFA7WWJ2
ValerianACTIVE INGREDIENTJWF5YAW3QW2
Angelica Sinensis RootACTIVE MOIETYB66F4574UG2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Black CohoshACTIVE MOIETYK73E24S6X92
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
Caulophyllum Thalictroides RootACTIVE MOIETYJTJ6HH6YEH2
Chamaelirium Luteum RootACTIVE MOIETYDQV54Y5H3U2
Chaste TreeACTIVE MOIETY433OSF3U8A2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9562
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369802
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM2
NitroglycerinACTIVE MOIETYG59M7S0WS32
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Salix Nigra BarkACTIVE MOIETYQU52J3A5B32
Sanguinaria Canadensis RootACTIVE MOIETYN9288CD5082
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Turnera Diffusa Leafy TwigACTIVE MOIETYRQ2CFA7WWJ2
ValerianACTIVE MOIETYJWF5YAW3QW2
SucroseINACTIVE INGREDIENTC151H8M5542

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-223555714-2235-1, 55714-2235-2, 55714-2235-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f26cd39b-1c0a-f6cd-1250-169ab3e7654f9f04d505-7475-ef8a-57ab-eb820fb497262011-03-01WarningsExact identifier
spl id: f26cd39b-1c0a-f6cd-1250-169ab3e7654f
spl set id: 9f04d505-7475-ef8a-57ab-eb820fb49726

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.