Menorrhagia

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 02:05:10

Label at a glance#

ProductMenorrhagia

Active ingredientAletris Farinosa Root, Apocynum Cannabinum Root, Cinchona Officinalis Bark, Cinnamon, Conium Maculatum Flowering Top, Chamaelirium Luteum Root, Lilium Lancifolium Whole Flowering, Achillea Millefolium, Phosphorus, Claviceps Purpurea Sclerotium, Capsella Bursa-pastoris, Trillium Erectum Root, Apis Mellifera, Hamamelis Virginiana Root Bark/stem Bark, Goldenseal

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

Menorrhagia Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

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

Aletris 15x, Apocynum 15x, Cinchona 15x, Cinnamomum 15x, Conium 15x, Helonias dioica 15x, Lilium 15x, Millefolium 15x, Phosphorus 15x, Secale 15x, Thlaspi 15x, Trillium pendulum 15x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4521-1	2020-01-31	C162847	48780-1	9d75b9cf-f734-f424-e053-dadaa90a57ce	Menorrhagia
55714-4521-2	2020-01-31	C162847	48780-1	9d75b9cf-f734-f424-e053-dadaa90a57ce	Menorrhagia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4521-1	Menorrhagia	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4521-2	Menorrhagia	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
55714-4521	MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131107_a6598a5b-5714-aae6-80ca-e9284fcb3c66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Achillea Millefolium	ACTIVE INGREDIENT	2FXJ6SW4PK	1
Aletris Farinosa Root	ACTIVE INGREDIENT	O021JGR97X	1
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	1
Apocynum Cannabinum Root	ACTIVE INGREDIENT	2F92409L9Z	1
Capsella Bursa-pastoris	ACTIVE INGREDIENT	W0X9457M59	1
Chamaelirium Luteum Root	ACTIVE INGREDIENT	DQV54Y5H3U	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Cinnamon	ACTIVE INGREDIENT	5S29HWU6QB	1
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE INGREDIENT	T7S323PKJS	1
Lilium Lancifolium Whole Flowering	ACTIVE INGREDIENT	X67Z2963PI	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Trillium Erectum Root	ACTIVE INGREDIENT	AHW6F0T2X0	1
Achillea Millefolium	ACTIVE MOIETY	2FXJ6SW4PK	1
Aletris Farinosa Root	ACTIVE MOIETY	O021JGR97X	1
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	1
Apocynum Cannabinum Root	ACTIVE MOIETY	2F92409L9Z	1
Capsella Bursa-pastoris	ACTIVE MOIETY	W0X9457M59	1
Chamaelirium Luteum Root	ACTIVE MOIETY	DQV54Y5H3U	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Cinnamon	ACTIVE MOIETY	5S29HWU6QB	1
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE MOIETY	T7S323PKJS	1
Lilium Lancifolium Whole Flowering	ACTIVE MOIETY	X67Z2963PI	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Trillium Erectum Root	ACTIVE MOIETY	AHW6F0T2X0	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Menorrhagia
Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis
Aletris Farinosa Root
Apocynum Cannabinum Root
Cinchona Officinalis Bark
Cinnamon
Conium Maculatum Flowering Top
Chamaelirium Luteum Root
Lilium Lancifolium Whole Flowering
Achillea Millefolium
Phosphorus
Claviceps Purpurea Sclerotium
Capsella Bursa-pastoris
Trillium Erectum Root
Apis Mellifera
Hamamelis Virginiana Root Bark/stem Bark
Goldenseal
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4521	55714-4521-1, 55714-4521-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Aletris Farinosa Root	O021JGR97X	ACTIB
Apocynum Cannabinum Root	2F92409L9Z	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Cinnamon	5S29HWU6QB	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Chamaelirium Luteum Root	DQV54Y5H3U	ACTIB
Lilium Lancifolium Whole Flowering	X67Z2963PI	ACTIB
Achillea Millefolium	2FXJ6SW4PK	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Claviceps Purpurea Sclerotium	01G9XEA93N	ACTIB
Capsella Bursa-pastoris	W0X9457M59	ACTIB
Trillium Erectum Root	AHW6F0T2X0	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Hamamelis Virginiana Root Bark/stem Bark	T7S323PKJS	ACTIB
Goldenseal	ZW3Z11D0JV	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	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 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	LOZENGE / TRANSMUCOSAL		1255 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, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 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	INJECTION / INTRAVENOUS		1950 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	INJECTION, SOLUTION / INTRAVENOUS	NA		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	DROPS / ORAL	NA		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	TABLET / BUCCAL	109 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	SOLUTION / ORAL		70000 mg	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	POWDER / ORAL		27768 mg	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	GRANULE, FOR SOLUTION / ORAL		42596 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	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 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, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		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	TABLET, DELAYED RELEASE / ORAL	295.33 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	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 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	TABLET, EXTENDED RELEASE / ORAL	284.54 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	POWDER, FOR SUSPENSION / ORAL		40017 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	SOLUTION / RECTAL	35.42 %w/v		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	SUPPOSITORY / RECTAL	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	TABLET / ORAL		4249 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	GRANULE / ORAL	NA		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	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	SUSPENSION/ DROPS / ORAL		3750 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	CAPSULE, COATED PELLETS / ORAL	59.8 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

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
bafa54f7-58e2-4499-46df-321ada366b7d			a6598a5b-5714-aae6-80ca-e9284fcb3c66	2011-06-01	Warnings	Exact identifier spl id: bafa54f7-58e2-4499-46df-321ada366b7d spl set id: a6598a5b-5714-aae6-80ca-e9284fcb3c66

Reported adverse events (FAERS/openFDA)#

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