Headache - Migraine

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 02:05:07

Label at a glance#

ProductHeadache - Migraine

Active ingredientMicrurus Corallinus Venom, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Centaurea Benedicta, Black Cohosh, Arabica Coffee Bean, Convallaria Majalis, Crotalus Horridus Horridus Venom, Digitalis, Gelsemium Sempervirens Root, Nitroglycerin, Strychnos Ignatii Seed, Lachesis Muta Venom, Mercury, Naja Naja Venom, Strychnos Nux-vomica Seed, Phosphorus, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Claviceps Purpurea Sclerotium, Vipera Berus Venom, Apis Mellifera, Hypericum Perforatum, Thuja Occidentalis Leafy Twig

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

HEADACHE - MIGRAINE Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

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
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
55714-4445-1	2020-01-31	C162847	48780-1	9d75b9d0-5779-f424-e053-dadaa90a57ce	Headache - Migraine
55714-4445-2	2020-01-31	C162847	48780-1	9d75b9d0-5779-f424-e053-dadaa90a57ce	Headache - Migraine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4445-1	Headache - Migraine	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4445-2	Headache - Migraine	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
55714-4445	HEADACHE - MIGRAINE (ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC.) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131030_af25d44a-3ef1-43e5-ec41-121dcb484c5a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	1
Arabica Coffee Bean	ACTIVE INGREDIENT	3SW678MX72	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	1
Black Cohosh	ACTIVE INGREDIENT	K73E24S6X9	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Centaurea Benedicta	ACTIVE INGREDIENT	6L5ZL09795	1
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	1
Convallaria Majalis	ACTIVE INGREDIENT	QHH4HVF5QE	1
Crotalus Horridus Horridus Venom	ACTIVE INGREDIENT	YHA2XLJ956	1
Digitalis	ACTIVE INGREDIENT	F1T8QT9U8B	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	1
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	1
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	1
Micrurus Corallinus Venom	ACTIVE INGREDIENT	V0S6H36980	1
Naja Naja Venom	ACTIVE INGREDIENT	ZZ4AG7L7VM	1
Nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Sanguinaria Canadensis Root	ACTIVE INGREDIENT	N9288CD508	1
Strychnos Ignatii Seed	ACTIVE INGREDIENT	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Vipera Berus Venom	ACTIVE INGREDIENT	0ORO6NCA4M	1
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	1
Arabica Coffee Bean	ACTIVE MOIETY	3SW678MX72	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	1
Black Cohosh	ACTIVE MOIETY	K73E24S6X9	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Centaurea Benedicta	ACTIVE MOIETY	6L5ZL09795	1
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	1
Convallaria Majalis	ACTIVE MOIETY	QHH4HVF5QE	1
Crotalus Horridus Horridus Venom	ACTIVE MOIETY	YHA2XLJ956	1
Digitalis	ACTIVE MOIETY	F1T8QT9U8B	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	1
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	1
Mercury	ACTIVE MOIETY	FXS1BY2PGL	1
Micrurus Corallinus Venom	ACTIVE MOIETY	V0S6H36980	1
Naja Naja Venom	ACTIVE MOIETY	ZZ4AG7L7VM	1
Nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Sanguinaria Canadensis Root	ACTIVE MOIETY	N9288CD508	1
Strychnos Ignatii Seed	ACTIVE MOIETY	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Vipera Berus Venom	ACTIVE MOIETY	0ORO6NCA4M	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

Headache - Migraine
Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.
Micrurus Corallinus Venom
Arsenic Trioxide
Arsenic Cation (3+)
Atropa Belladonna
Bryonia Alba Root
Centaurea Benedicta
Black Cohosh
Arabica Coffee Bean
Convallaria Majalis
Crotalus Horridus Horridus Venom
Digitalis
Gelsemium Sempervirens Root
Nitroglycerin
Strychnos Ignatii Seed
Lachesis Muta Venom
Mercury
Naja Naja Venom
Strychnos Nux-vomica Seed
Phosphorus
Toxicodendron Pubescens Leaf
Sanguinaria Canadensis Root
Claviceps Purpurea Sclerotium
Vipera Berus Venom
Apis Mellifera
Hypericum Perforatum
Thuja Occidentalis Leafy Twig
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4445	55714-4445-1, 55714-4445-2

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
Arsenic Trioxide	S7V92P67HO	ACTIB
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Centaurea Benedicta	6L5ZL09795	ACTIB
Black Cohosh	K73E24S6X9	ACTIB
Arabica Coffee Bean	3SW678MX72	ACTIB
Convallaria Majalis	QHH4HVF5QE	ACTIB
Crotalus Horridus Horridus Venom	YHA2XLJ956	ACTIB
Digitalis	F1T8QT9U8B	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Nitroglycerin	G59M7S0WS3	ACTIB
Strychnos Ignatii Seed	1NM3M2487K	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Naja Naja Venom	ZZ4AG7L7VM	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Sanguinaria Canadensis Root	N9288CD508	ACTIB
Claviceps Purpurea Sclerotium	01G9XEA93N	ACTIB
Vipera Berus Venom	0ORO6NCA4M	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	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	SUPPOSITORY / RECTAL	NA		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, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	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	POWDER, FOR SUSPENSION / ORAL		40017 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	INJECTION, EMULSION / INTRAVENOUS		970 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	SOLUTION / ORAL		70000 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	LIQUID / ORAL		37500 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 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	TABLET / ORAL		4249 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 SOLUTION / ORAL		42596 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	CAPSULE, EXTENDED RELEASE / ORAL		619 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	DROPS / ORAL	NA		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	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 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	TROCHE / BUCCAL	NA		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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 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	TABLET, FILM COATED / ORAL		145 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	GRANULE, FOR SUSPENSION / ORAL		31885 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	TABLET, EXTENDED RELEASE / ORAL	284.54 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	CAPSULE, DELAYED RELEASE / ORAL		955 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	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 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	TABLET, DELAYED RELEASE / ORAL	295.33 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	INJECTION / SUBCUTANEOUS	47.75 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	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 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	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 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	SUSPENSION / ORAL		48209 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

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
ce552a8e-4374-10a3-c8ac-c725fa9c6fa2			af25d44a-3ef1-43e5-ec41-121dcb484c5a	2011-06-01	Warnings	Exact identifier spl id: ce552a8e-4374-10a3-c8ac-c725fa9c6fa2 spl set id: af25d44a-3ef1-43e5-ec41-121dcb484c5a

Reported adverse events (FAERS/openFDA)#

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