Menopause

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:04:53

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

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: ORAL USE ONLY - SHAKE WELL. Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 35x, Agnus 15x, Angelica sinensis radix 15x, Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x, Caulophyllum 15x, Cimicifuga 15x, Cinchona 15x, Crotalus horridus 15x, Damiana 15x, Glonoinum 15x, Helonias dioica 15x, Ignatia 15x, Kali carb. 15x, Lachesis 15x, Naja 15x, Nux vom.15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Echinacea 8x, Valeriana 8x, Echinacea 3x, Valeriana3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7480e90b-004b-ebe4-2243-4f2fefdd9e78	Product name	2	20260128
3f158398-73f2-4b90-47d1-5c60e8719a98	Product name	9	20250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0	Product name	2	20250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
669af5aa-14f3-3df7-f100-5f580ffd43c1	Product name	1	20140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fb	Product name	1	20140508
8bb82a1c-d0d0-fc27-011f-172e545f0382	Product name	1	20140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4456-1	2020-01-31	C162847	48780-1	9d75b9d0-6aa2-f424-e053-dadaa90a57ce	Menopause
55714-4456-2	2020-01-31	C162847	48780-1	9d75b9d0-6aa2-f424-e053-dadaa90a57ce	Menopause

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4456-1	Menopause	29.57 mL in 1 BOTTLE, GLASS	LIQUID	29.57		2
55714-4456-2	Menopause	59.14 mL in 1 BOTTLE, GLASS	LIQUID	59.14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4456	MENOPAUSE (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) LIQUID [NEWTON LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20130821_c81ca29c-fae6-d796-d003-51fe7001b635.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Angelica Sinensis Root	ACTIVE INGREDIENT	B66F4574UG	2
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	2
Black Cohosh	ACTIVE INGREDIENT	K73E24S6X9	2
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	2
Caulophyllum Thalictroides Root	ACTIVE INGREDIENT	JTJ6HH6YEH	2
Chamaelirium Luteum Root	ACTIVE INGREDIENT	DQV54Y5H3U	2
Chaste Tree	ACTIVE INGREDIENT	433OSF3U8A	2
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	2
Crotalus Horridus Horridus Venom	ACTIVE INGREDIENT	YHA2XLJ956	2
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	2
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	2
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	2
Micrurus Corallinus Venom	ACTIVE INGREDIENT	V0S6H36980	2
Naja Naja Venom	ACTIVE INGREDIENT	ZZ4AG7L7VM	2
Nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	2
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	2
Potassium Carbonate	ACTIVE INGREDIENT	BQN1B9B9HA	2
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	2
Salix Nigra Bark	ACTIVE INGREDIENT	QU52J3A5B3	2
Sanguinaria Canadensis Root	ACTIVE INGREDIENT	N9288CD508	2
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	2
Strychnos Ignatii Seed	ACTIVE INGREDIENT	1NM3M2487K	2
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	2
Turnera Diffusa Leafy Twig	ACTIVE INGREDIENT	RQ2CFA7WWJ	2
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	2
Angelica Sinensis Root	ACTIVE MOIETY	B66F4574UG	2
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	2
Black Cohosh	ACTIVE MOIETY	K73E24S6X9	2
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	2
Carbonate Ion	ACTIVE MOIETY	7UJQ5OPE7D	2
Caulophyllum Thalictroides Root	ACTIVE MOIETY	JTJ6HH6YEH	2
Chamaelirium Luteum Root	ACTIVE MOIETY	DQV54Y5H3U	2
Chaste Tree	ACTIVE MOIETY	433OSF3U8A	2
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	2
Crotalus Horridus Horridus Venom	ACTIVE MOIETY	YHA2XLJ956	2
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	2
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	2
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	2
Micrurus Corallinus Venom	ACTIVE MOIETY	V0S6H36980	2
Naja Naja Venom	ACTIVE MOIETY	ZZ4AG7L7VM	2
Nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	2
Phosphorus	ACTIVE MOIETY	27YLU75U4W	2
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	2
Salix Nigra Bark	ACTIVE MOIETY	QU52J3A5B3	2
Sanguinaria Canadensis Root	ACTIVE MOIETY	N9288CD508	2
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	2
Strychnos Ignatii Seed	ACTIVE MOIETY	1NM3M2487K	2
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	2
Turnera Diffusa Leafy Twig	ACTIVE MOIETY	RQ2CFA7WWJ	2
Valerian	ACTIVE MOIETY	JWF5YAW3QW	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	2

Products#

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

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

Menopause
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
Micrurus Corallinus Venom
Chaste Tree
Angelica Sinensis Root
Arsenic Trioxide
Arsenic Cation (3+)
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
Carbonate Ion
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
Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4456	55714-4456-1, 55714-4456-2

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Micrurus Corallinus Venom	V0S6H36980	ACTIB
Chaste Tree	433OSF3U8A	ACTIB
Angelica Sinensis Root	B66F4574UG	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Caulophyllum Thalictroides Root	JTJ6HH6YEH	ACTIB
Black Cohosh	K73E24S6X9	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Crotalus Horridus Horridus Venom	YHA2XLJ956	ACTIB
Turnera Diffusa Leafy Twig	RQ2CFA7WWJ	ACTIB
Nitroglycerin	G59M7S0WS3	ACTIB
Chamaelirium Luteum Root	DQV54Y5H3U	ACTIB
Strychnos Ignatii Seed	1NM3M2487K	ACTIB
Potassium Carbonate	BQN1B9B9HA	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Naja Naja Venom	ZZ4AG7L7VM	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Salix Nigra Bark	QU52J3A5B3	ACTIB
Sanguinaria Canadensis Root	N9288CD508	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Valerian	JWF5YAW3QW	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	INJECTION / SUBCUTANEOUS		149 mg	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
Alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		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	GEL / TRANSDERMAL		7360 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	ELIXIR / ORAL		13675 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	INJECTION / INTRAVASCULAR	100 %v/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	SUSPENSION / RECTAL	0.35 %v/v		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	TABLET, DELAYED RELEASE / ORAL	NA		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	SOLUTION / DENTAL	12.8 %w/w		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	SOLUTION / INTRAVESICAL		7892 mg	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	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		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	AEROSOL / TOPICAL		561 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	CAPSULE, EXTENDED RELEASE / ORAL		8 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	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 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	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 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 / TOPICAL		561 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	GEL / RECTAL		898 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	SOLUTION / ORAL		6624 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	AEROSOL, METERED / NASAL	70 mg		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	CONCENTRATE / ORAL	198 mg		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	SWAB / TOPICAL		2250 mg	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	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		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	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	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	DROPS / ORAL	210 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	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	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	SPRAY, METERED / SUBLINGUAL		29 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	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		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, METERED / TRANSDERMAL		3675 mg	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	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		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	SOLUTION / TOPICAL		2445 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

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
4111fe91-80da-1c8f-2d0d-6c6522cc6870			c81ca29c-fae6-d796-d003-51fe7001b635	2011-06-01	Warnings	Exact identifier spl id: 4111fe91-80da-1c8f-2d0d-6c6522cc6870 spl set id: c81ca29c-fae6-d796-d003-51fe7001b635

Reported adverse events (FAERS/openFDA)#

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