Edometriosis

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:39:09

Label at a glance#

ProductEdometriosis
Active ingredientArsenic Trioxide, Bryonia Alba Root, Black Cohosh, Cinchona Officinalis Bark, Goldenseal, Iodine, Lachesis Muta Venom, Lilium Lancifolium Whole Flowering, Lycopodium Clavatum Spore, Phosphorus, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Juniperus Sabina Leafy Twig, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Apis Mellifera, Hamamelis Virginiana Root Bark/stem Bark, Conium Maculatum Flowering Top
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Endometriosis   Formulated for associated symptoms such as menorrhagia, dysmenorrhea, dyspareunia and infertility.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:   Ages 12 and up, take 6 pellets orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Bryonia 10x, Cimicifuga 10x, Cinchona 10x, Conium 10x, Hydrastis 10x, Iodium 10x, Lachesis 10x, Lilium 10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Sabina 10x, Secale 10x, Sepia 10x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for associated symptoms such as menorrhagia, dysmenorrhea, dyspareunia and infertility.

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.

PREGNANCY OR BREAST FEEDING SECTION

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. 

KEEP OUT OF REACH OF CHILDREN SECTION

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Black CohoshACTIVE INGREDIENTK73E24S6X91
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Claviceps Purpurea SclerotiumACTIVE INGREDIENT01G9XEA93N1
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3711
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
IodineACTIVE INGREDIENT9679TC07X41
Juniperus Sabina Leafy TwigACTIVE INGREDIENTZ5BEX9K2G11
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lilium Lancifolium Whole FloweringACTIVE INGREDIENTX67Z2963PI1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Black CohoshACTIVE MOIETYK73E24S6X91
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Claviceps Purpurea SclerotiumACTIVE MOIETY01G9XEA93N1
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3711
GoldensealACTIVE MOIETYZW3Z11D0JV1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
IodineACTIVE MOIETY9679TC07X41
Juniperus Sabina Leafy TwigACTIVE MOIETYZ5BEX9K2G11
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lilium Lancifolium Whole FloweringACTIVE MOIETYX67Z2963PI1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
SucroseINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-449355714-4493-1, 55714-4493-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 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
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 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
98bdc970-2ec4-153d-e053-2a95a90a8a0fcce9998b-1d26-04ae-ebd5-302be37b538a2019-12-02WarningsExact identifier
spl set id: cce9998b-1d26-04ae-ebd5-302be37b538a

Reported adverse events (FAERS/openFDA)#

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