FDA.reportPublic FDA data

Headache Relief

Manufacturer
King Bio Inc.
Effective date
2012-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:39

Label at a glance#

ProductHeadache Relief
Active ingredientATROPA BELLADONNA, BRYONIA ALBA ROOT, CAPSICUM, QUININE ARSENITE, ARABICA COFFEE BEAN, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, STRYCHNOS IGNATII SEED, POTASSIUM DICHROMATE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA, SULFUR
Label structure8 sections

Indications and uses

Uses for temporary relief of headache pain: throbbing/splitting, tight/bursting, sinus/congestive, migraine/occipital, dull/sick, band feeling around head, morning headache, sun headache Reference image headacherelief.jpg

Dosage and administration

Directions: Initially, depress pump until primed.  Hold close to mouth and spray directly into mouth.  Use 3 times daily.  Use additionally as needed. Adult Dose - 3 pump sprays Children (2-12 years) - 2 pump sprays Reference image headacherelief.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur.

Reference image headacherelief.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, consult a physician.  If pregnant or nursing, take only on advice of healthcare professional.  Keep out of reach of children.

Other: Tamper resistant for your protection.  Use only if safety seal is intact.

Reference image headacherelief.jpg

Purposes

OTC - PURPOSE SECTION

Uses for temporary relief of headache pain:

  • throbbing / splitting
  • tight / bursting
  • sinus / congestive
  • migraine / occipital
  • dull / sick
  • band feeling around head
  • morning headache
  • sun headache
Reference image headacherelief.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for temporary relief of headache pain: throbbing/splitting, tight/bursting, sinus/congestive, migraine/occipital, dull/sick, band feeling around head, morning headache, sun headache

Reference image headacherelief.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image headacherelief.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Initially, depress pump until primed.  Hold close to mouth and spray directly into mouth.  Use 3 times daily.  Use additionally as needed.

Adult Dose - 3 pump sprays

Children (2-12 years) - 2 pump sprays

Reference image headacherelief.jpg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Reference image headacherelief.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

King Bio, Inc.

3 Westside Dr

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com


DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5153-22020-01-31C16284748780-19d75b9d0-2bae-f424-e053-dadaa90a57ceHeadache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5153-2Headache Relief59 mL in 1 BOTTLE, SPRAYSPRAY592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5153HEADACHE RELIEF (BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CHININUM ARSENICOSUM, COFFEA CRUDA, GELSEMIUM SEMPERVIRENS, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SANGUINARIA CANADENSIS, SPIGELIA ANTHELMIA, SULPHUR.) SPRAY [KING BIO INC.]2Legacy NDC, 1 package rows20120403_a45f2b6f-c2c4-4265-8039-d6bc4e8f32d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX722
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B2
CAPSICUMACTIVE INGREDIENT00UK7646FG2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS32
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM2
QUININE ARSENITEACTIVE INGREDIENT42QO5P0NLM2
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5082
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X2
SPIGELIA ANTHELMIAACTIVE INGREDIENTWYT05213GE2
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K2
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139192
SULFURACTIVE INGREDIENT70FD1KFU702
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX722
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B2
CAPSICUMACTIVE MOIETY00UK7646FG2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
NITROGLYCERINACTIVE MOIETYG59M7S0WS32
POTASSIUM CATIONACTIVE MOIETY295O53K1522
QUININE ARSENITEACTIVE MOIETY42QO5P0NLM2
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5082
SODIUM CATIONACTIVE MOIETYLYR4M0NH372
SPIGELIA ANTHELMIAACTIVE MOIETYWYT05213GE2
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K2
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139192
SULFURACTIVE MOIETY70FD1KFU702
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-515357955-5153-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAPSICUM00UK7646FGACTIB
QUININE ARSENITE42QO5P0NLMACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITROGLYCERING59M7S0WS3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
SULFUR70FD1KFU70ACTIB
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
0eaa6e75-6de5-41ca-b252-e6c306121bcaa45f2b6f-c2c4-4265-8039-d6bc4e8f32d62012-04-02WarningsExact identifier
spl id: 0eaa6e75-6de5-41ca-b252-e6c306121bca
spl set id: a45f2b6f-c2c4-4265-8039-d6bc4e8f32d6

Reported adverse events (FAERS/openFDA)#

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