FDA.reportPublic FDA data

Lab1796 Headache Ease

Manufacturer
HomeopathyStore.com
Effective date
2011-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:16

Label at a glance#

ProductLab1796 Headache Ease
Active ingredientATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEE BEAN, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARK
Label structure6 sections

Indications and uses

For the temporary relief of migraines, tension and general headaches.

Dosage and administration

Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.

Label contents#

Full prescribing information#

Uses:

OTC - PURPOSE SECTION

For the temporary relief of migraines, tension and general headaches.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

(HPUS) Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sucrose/lactose

Directions:

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.

Warnings:

WARNINGS SECTION

If symptoms persist or worsen or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59875-4005-12020-01-31C16284748780-19d75b9d0-1ec1-f424-e053-dadaa90a57ceHeadache Ease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59875-4005-1Lab1796 Headache Ease85 in 1 TUBEPELLET851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59875-4005LAB1796 HEADACHE EASE (ATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEE BEAN, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARK) PELLET [HOMEOPATHYSTORE.COM]1Legacy NDC, 1 package rows20110812_bf4a75fd-c315-4885-bae1-52d0007c4ad0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
COFFEE BEANACTIVE INGREDIENTJFH385Y7441
CYCLAMEN PURPURASCENS TUBERACTIVE INGREDIENTG728143D8Q1
IRIS VERSICOLOR ROOTACTIVE INGREDIENTX43D4L3DQC1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SPIGELIA MARILANDICA ROOTACTIVE INGREDIENT467D26HS0B1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VIBURNUM OPULUS BARKACTIVE INGREDIENTT1UG6H68051
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
COFFEE BEANACTIVE MOIETYJFH385Y7441
CYCLAMEN PURPURASCENS TUBERACTIVE MOIETYG728143D8Q1
IRIS VERSICOLOR ROOTACTIVE MOIETYX43D4L3DQC1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SPIGELIA MARILANDICA ROOTACTIVE MOIETY467D26HS0B1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VIBURNUM OPULUS BARKACTIVE MOIETYT1UG6H68051
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59875-400559875-4005-1
61727-305

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
COFFEE BEANJFH385Y744ACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SPIGELIA MARILANDICA ROOT467D26HS0BACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARKHomeocare Laboratories47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f2026-01-12WarningsExact identifier
ndc (product): 61727-305
27c8c1b9-1bb8-4385-9f7d-af595d6d09f9bf4a75fd-c315-4885-bae1-52d0007c4ad02011-08-01WarningsExact identifier
spl id: 27c8c1b9-1bb8-4385-9f7d-af595d6d09f9
spl set id: bf4a75fd-c315-4885-bae1-52d0007c4ad0

Reported adverse events (FAERS/openFDA)#

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