FDA.reportPublic FDA data

Headache Soothe

Manufacturer
Feelgood Health | W. Last
Effective date
2010-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:02:29

Label at a glance#

ProductHeadache Soothe
Active ingredientAILANTHUS ALTISSIMA FLOWERING TWIG, STRYCHNOS NUX-VOMICA SEED, CHAMOMILE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves headaches and nervous tension

INDICATIONS & USAGE SECTION

Indications: Homeopathic remedy for headache relief.

DOSAGE & ADMINISTRATION SECTION

Dosage: Mix 10 drops in ¼ cup water and sip slowly. Repeat every 20-30 minutes as needed until symptoms subside. If preferred, drops may be taken directly into the mouth. Children under 12: Reduce dosage to 5 drops.

GENERAL PRECAUTIONS SECTION

Caution: Consult your doctor if symptoms persist or worsen. Keep this and all medicines out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

Ingredients: Each dose contains equal parts of China (12C) (HPUS), Nux vom (12C) (HPUS), Chamomilla (12C) (HPUS), Kali phos (6X) (HPUS), Mag phos (6X) (HPUS)

INACTIVE INGREDIENT SECTION

Citricidal Extract (inactive ingredient).

PREGNANCY SECTION

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

WARNINGS SECTION

Contains no animal products, gluten, artificial flavors, preservatives, colorants or alcohol. Suitable for vegetarians and safe for all ages.

INFORMATION FOR PATIENTS SECTION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
68647-171-102019-10-21C16284748780-1956f9ecf-c07b-621f-e053-dbdaa90a74adHEADACHE SOOTHE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68647-171-10Headache Soothe50000 mL in 1 BOTTLE, GLASSTINCTURE500002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68647-171HEADACHE SOOTHE (CHINA , NUX VOM, CHAMOMILLA, KALI PHOS , MAG PHOS ) TINCTURE [FEELGOOD HEALTH]2Legacy NDC, 1 package rows20100823_94a70bbd-0ea5-47af-97d9-400485a2109d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AILANTHUS ALTISSIMA FLOWERING TWIGACTIVE INGREDIENT8P29O5P7XU2
CHAMOMILEACTIVE INGREDIENTFGL3685T2X2
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q2
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z2
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139192
AILANTHUS ALTISSIMA FLOWERING TWIGACTIVE MOIETY8P29O5P7XU2
CHAMOMILEACTIVE MOIETYFGL3685T2X2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8382
POTASSIUM CATIONACTIVE MOIETY295O53K1522
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139192
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68647-17168647-171-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
AILANTHUS ALTISSIMA FLOWERING TWIG8P29O5P7XUACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
CHAMOMILEFGL3685T2XACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
WATER059QF0KO0RIACT

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
effedad7-579e-45c7-9e6c-66c42d9bd2bb94a70bbd-0ea5-47af-97d9-400485a2109d2010-07-29WarningsExact identifier
spl id: effedad7-579e-45c7-9e6c-66c42d9bd2bb
spl set id: 94a70bbd-0ea5-47af-97d9-400485a2109d

Reported adverse events (FAERS/openFDA)#

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