FDA.reportPublic FDA data

NativeRemedies® Migraine Ease Tablets

Manufacturer
Silver Star Brands | OHM Pharma, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:59

Label at a glance#

ProductMigraine Ease
Active ingredientATROPA BELLADONNA, SPIGELIA ANTHELMIA, SANGUINARIA CANADENSIS ROOT, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, BRYONIA ALBA ROOT, NITROGLYCERIN, SEPIA OFFICINALIS JUICE, ACTAEA CIMICIFUGA ROOT, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED
Label structure10 sections

Indications and uses

Uses*: Homeopathic remedy for migraine headache symptoms. *Claims based on traditional homeopathic practice, not accpeted medical evidence. Not FDA evaluated.

Dosage and administration

Directions: Chew or dissolve tablets in the mouth. For Adults and Children 12+: Take 2 tablets every 15-20 minutes up to 4 doses, then every 4 hours until symptoms subside.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volumes of each ingredient in a 12C potency: Belladonna, Bryonia, Cimicifuga, Gelsemium, Glonoinum, Ignatia, Iris vers, Nux vom, Sanguinaria, Sepia, Spigelia anth.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy for migraine headache symptoms.

*Claims based on traditional homeopathic practice, not accpeted medical evidence. Not FDA evaluated.

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Chew or dissolve tablets in the mouth. For Adults and Children 12+: Take 2 tablets every 15-20 minutes up to 4 doses, then every 4 hours until symptoms subside.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added. Lactose-free.

Tamper resistant for your protection. use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Magnesium Stearate, Maltodextrin, Sucrose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Temporarily relieves migraine headache symptoms*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Migraine Ease labelMigraine Ease label

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-375-802023-12-26C16284748780-1f386c64a-410c-0266-e053-dadaa90a7c1aNativeRemedies® Migraine Ease Tablets
68703-375-802023-01-30C16284748780-1f386c64a-410c-0266-e053-dadaa90a7c1aNativeRemedies® Migraine Ease Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-375-80Migraine Ease180 in 1 BOTTLE, GLASSTABLET1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-375MIGRAINE EASE (BELLADONNA, BRYONIA, CIMICIFUGA, GELSEMIUM, GLONOINUM, IGNATIA, IRIS VERS, NUX VOM, SANGUINARIA, SEPIA, SPIGELIA ANTH) TABLET [SILVER STAR BRANDS]4Current NDC, Legacy NDC, 1 package rows20250103_c68ab321-7105-0e54-e053-2995a90a298a.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-37568703-375-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
MAGNESIUM STEARATE70097M6I30IACT
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
MALTODEXTRIN7CVR7L4A2DIACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
NITROGLYCERING59M7S0WS3ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
ACTAEA CIMICIFUGA ROOT65J267BAZTACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Migraine EaseBELLADONNA, BRYONIA, CIMICIFUGA, GELSEMIUM, GLONOINUM, IGNATIA, IRIS VERS, NUX VOM, SANGUINARIA, SEPIA, SPIGELIA ANTHSilver Star Brandsc68ab321-7105-0e54-e053-2995a90a298a2025-01-01WarningsExact identifier
ndc (package): 68703-375-80
ndc (product): 68703-375
ndc11 (package): 68703037580
spl id: 2ab0f647-0254-0e1c-e063-6294a90a74b2
spl set id: c68ab321-7105-0e54-e053-2995a90a298a

Reported adverse events (FAERS/openFDA)#

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