NativeRemedies® Headache 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#

ProductHeadache Ease
Active ingredientSTRYCHNOS NUX-VOMICA SEED, POTASSIUM PHOSPHATE, DIBASIC, SEPIA OFFICINALIS JUICE, ATROPA BELLADONNA, GOLD, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED, BRYONIA ALBA ROOT, SODIUM CHLORIDE
Label structure10 sections

Indications and uses

Uses*: Homeopathic relief of common headache symptoms.

Dosage and administration

Directions: Chew or dissolve tablets int he 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: Aur met, Belladonna, Bryonia, Gelsemium, Ignatia, Kali phos, Nat mur, Nux vom, Sepia.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Homeopathic relief of common headache symptoms.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Chew or dissolve tablets int he 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 common headache symptoms*

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Headache Ease labelHeadache Ease label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-374-802023-12-26C16284748780-1f386c649-b895-0266-e053-dadaa90a7c1aNativeRemedies® Headache Ease Tablets
68703-374-802023-01-30C16284748780-1f386c649-b895-0266-e053-dadaa90a7c1aNativeRemedies® Headache Ease Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-374-80Headache Ease180 in 1 BOTTLE, GLASSTABLET1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-374HEADACHE EASE (AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA) TABLET [SILVER STAR BRANDS]4Current NDC, Legacy NDC, 1 package rows20250103_c689fb16-6200-ac94-e053-2995a90a703d.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
68703-37468703-374-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
ndc (package): 68703-374-80
ndc (product): 68703-374
ndc11 (package): 68703037480
spl id: 2ab0f66a-fdb4-1f10-e063-6294a90af7bc
spl set id: c689fb16-6200-ac94-e053-2995a90a703d

Reported adverse events (FAERS/openFDA)#

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