FDA.reportPublic FDA data

Headache

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:38

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Hypericum 6x, Thuja occ. 6x, Arsenicum alb.15x, Belladonna 15x, Bryonia 15x, Carduus ben. 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus hor. 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phos. 15x, Rhus tox. 15x, Sanguinaria 15x, Secale 15x, Vipera 15x, Elaps 30x.

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

PACKAGE LABEL

Label Images#

N013-L01
N013-L01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2453-1Headache30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2453HEADACHE (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..) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201201_9ab2a6e7-4e4f-e232-e053-2a95a90a66cb.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-245355714-2453-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
BLACK COHOSHK73E24S6X9ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
DIGITALISF1T8QT9U8BACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITROGLYCERING59M7S0WS3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURYFXS1BY2PGLACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
VIPERA BERUS VENOM0ORO6NCA4MACTIB
APIS MELLIFERA7S82P3R43ZACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Hypericum 6x, Thuja occ. 6x, Arsenicum alb.15x, Belladonna 15x, Bryonia 15x, Carduus ben. 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus hor. 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phos. 15x, Rhus tox. 15x, Sanguinaria 15x, Secale 15x, Vipera 15x, Elaps 30x.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - 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

Source Document#

Source XML