Menorrhagia

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:05:27

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: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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
55714-4520-1	2020-01-31	C162847	48780-1	9d75b9d0-7699-f424-e053-dadaa90a57ce	Menorrhagia
55714-4520-2	2020-01-31	C162847	48780-1	9d75b9d0-7699-f424-e053-dadaa90a57ce	Menorrhagia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4520-1	Menorrhagia	29.57 mL in 1 BOTTLE, GLASS	LIQUID	29.57		3
55714-4520-2	Menorrhagia	59.14 mL in 1 BOTTLE, GLASS	LIQUID	59.14		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4520	MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]	3	Legacy NDC, 2 package rows	20140211_6c0af311-292c-0f28-8a11-de712055e875.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Achillea Millefolium	ACTIVE INGREDIENT	2FXJ6SW4PK	3
Aletris Farinosa Root	ACTIVE INGREDIENT	O021JGR97X	3
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	3
Apocynum Cannabinum Root	ACTIVE INGREDIENT	2F92409L9Z	3
Capsella Bursa-pastoris	ACTIVE INGREDIENT	W0X9457M59	3
Chamaelirium Luteum Root	ACTIVE INGREDIENT	DQV54Y5H3U	3
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	3
Cinnamon	ACTIVE INGREDIENT	5S29HWU6QB	3
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	3
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	3
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	3
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE INGREDIENT	T7S323PKJS	3
Lilium Lancifolium Whole Flowering	ACTIVE INGREDIENT	X67Z2963PI	3
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	3
Trillium Erectum Root	ACTIVE INGREDIENT	AHW6F0T2X0	3
Achillea Millefolium	ACTIVE MOIETY	2FXJ6SW4PK	3
Aletris Farinosa Root	ACTIVE MOIETY	O021JGR97X	3
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	3
Apocynum Cannabinum Root	ACTIVE MOIETY	2F92409L9Z	3
Capsella Bursa-pastoris	ACTIVE MOIETY	W0X9457M59	3
Chamaelirium Luteum Root	ACTIVE MOIETY	DQV54Y5H3U	3
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	3
Cinnamon	ACTIVE MOIETY	5S29HWU6QB	3
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	3
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	3
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	3
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE MOIETY	T7S323PKJS	3
Lilium Lancifolium Whole Flowering	ACTIVE MOIETY	X67Z2963PI	3
Phosphorus	ACTIVE MOIETY	27YLU75U4W	3
Trillium Erectum Root	ACTIVE MOIETY	AHW6F0T2X0	3
Alcohol	INACTIVE INGREDIENT	3K9958V90M	3

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
Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4520	55714-4520-1, 55714-4520-2

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
Alcohol	3K9958V90M	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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 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
1bfd88ef-e0ef-7e9d-3ce8-3db9d1c5836b			6c0af311-292c-0f28-8a11-de712055e875	2011-06-01	Warnings	Exact identifier spl id: 1bfd88ef-e0ef-7e9d-3ce8-3db9d1c5836b spl set id: 6c0af311-292c-0f28-8a11-de712055e875

Reported adverse events (FAERS/openFDA)#

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