Female Fibroids

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:11

Label at a glance#

ProductFemale Fibroids

Active ingredientArsenic Trioxide, Calcium Iodide, Carbo Animalis, Conium Maculatum Flowering Top, Graphite, Goldenseal, Iodine, Wood Creosote, Lachesis Muta Venom, Phosphorus, Juniperus Sabina Leafy Twig, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Silicon Dioxide, Capsella Bursa-pastoris, Thuja Occidentalis Leafy Twig, Thyroid, Unspecified, Trillium Erectum Root, Ustilago Maydis

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

FEMALE FIBROIDS Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.

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. 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium 15x, Graphites 15x, Hydrastis 15x, Iodium 15x, Kreosotum 15x, Lachesis 15x, Phosphorus 15x, Sabina 15x, Secale 15x, Sepia 15x, Silicea 15x, Thlaspi 15x, Thuja occ. 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 15x, Hydrastis 3x, Thuja occ. 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.

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 or 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
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5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
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0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4593-1	2020-01-31	C162847	48780-1	9d75b9d0-dbe2-f424-e053-dadaa90a57ce	Female Fibroids
55714-4593-2	2020-01-31	C162847	48780-1	9d75b9d0-dbe2-f424-e053-dadaa90a57ce	Female Fibroids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4593-1	Female Fibroids	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4593-2	Female Fibroids	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4593	FEMALE FIBROIDS (ARSENICUM ALB., CLACAREA IODATA, CARBO ANIMALIS, CONIUM, GRAPHITES, HYDRASTIS, IODIUM, KREOSOTUM, LACHESIS, PHOSPHORUS, SABINA, SECALE, SEPIA, SILICEA, THLASPI, THUJA OCC., THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131112_a5ec1e7f-72f3-9672-2927-0c41415910b6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Calcium Iodide	ACTIVE INGREDIENT	8EKI9QEE2H	1
Capsella Bursa-pastoris	ACTIVE INGREDIENT	W0X9457M59	1
Carbo Animalis	ACTIVE INGREDIENT	279O8I0433	1
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Graphite	ACTIVE INGREDIENT	4QQN74LH4O	1
Iodine	ACTIVE INGREDIENT	9679TC07X4	1
Juniperus Sabina Leafy Twig	ACTIVE INGREDIENT	Z5BEX9K2G1	1
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	1
Silicon Dioxide	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Thyroid, Unspecified	ACTIVE INGREDIENT	0B4FDL9I6P	1
Trillium Erectum Root	ACTIVE INGREDIENT	AHW6F0T2X0	1
Ustilago Maydis	ACTIVE INGREDIENT	4K7Z7K7SWG	1
Wood Creosote	ACTIVE INGREDIENT	3JYG22FD73	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Calcium Cation	ACTIVE MOIETY	2M83C4R6ZB	1
Capsella Bursa-pastoris	ACTIVE MOIETY	W0X9457M59	1
Carbo Animalis	ACTIVE MOIETY	279O8I0433	1
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Graphite	ACTIVE MOIETY	4QQN74LH4O	1
Iodine	ACTIVE MOIETY	9679TC07X4	1
Juniperus Sabina Leafy Twig	ACTIVE MOIETY	Z5BEX9K2G1	1
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	1
Silicon Dioxide	ACTIVE MOIETY	ETJ7Z6XBU4	1
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	1
Thyroid, Unspecified	ACTIVE MOIETY	0B4FDL9I6P	1
Trillium Erectum Root	ACTIVE MOIETY	AHW6F0T2X0	1
Ustilago Maydis	ACTIVE MOIETY	4K7Z7K7SWG	1
Wood Creosote	ACTIVE MOIETY	3JYG22FD73	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Female Fibroids
Arsenicum alb., clacarea iodata, Carbo animalis, Conium, Graphites, Hydrastis, Iodium, Kreosotum, Lachesis, Phosphorus, Sabina, Secale, Sepia, Silicea, Thlaspi, Thuja occ., Thyroidinum, Trillium pendulum, Ustilago maidis
Arsenic Trioxide
Arsenic Cation (3+)
Calcium Iodide
Calcium Cation
Carbo Animalis
Conium Maculatum Flowering Top
Graphite
Goldenseal
Iodine
Wood Creosote
Lachesis Muta Venom
Phosphorus
Juniperus Sabina Leafy Twig
Claviceps Purpurea Sclerotium
Sepia Officinalis Juice
Silicon Dioxide
Capsella Bursa-pastoris
Thuja Occidentalis Leafy Twig
Thyroid, Unspecified
Trillium Erectum Root
Ustilago Maydis
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4593	55714-4593-1, 55714-4593-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Arsenic Trioxide	S7V92P67HO	ACTIB
Calcium Iodide	8EKI9QEE2H	ACTIB
Carbo Animalis	279O8I0433	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Graphite	4QQN74LH4O	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Iodine	9679TC07X4	ACTIB
Wood Creosote	3JYG22FD73	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Juniperus Sabina Leafy Twig	Z5BEX9K2G1	ACTIB
Claviceps Purpurea Sclerotium	01G9XEA93N	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Silicon Dioxide	ETJ7Z6XBU4	ACTIB
Capsella Bursa-pastoris	W0X9457M59	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Thyroid, Unspecified	0B4FDL9I6P	ACTIB
Trillium Erectum Root	AHW6F0T2X0	ACTIB
Ustilago Maydis	4K7Z7K7SWG	ACTIB
Sucrose	C151H8M554	IACT

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b65fde64-799e-6040-6f08-ff6f82b019a2			a5ec1e7f-72f3-9672-2927-0c41415910b6	2011-06-01	Warnings	Exact identifier spl id: b65fde64-799e-6040-6f08-ff6f82b019a2 spl set id: a5ec1e7f-72f3-9672-2927-0c41415910b6

Reported adverse events (FAERS/openFDA)#

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