FDA.reportPublic FDA data

Shellfish and Seafood Allergy Relief

Manufacturer
King Bio Inc.
Effective date
2012-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:50

Label at a glance#

ProductShellfish and Seafood Allergy Relief
Active ingredientEPINEPHRINE, ATROPA BELLADONNA, BROMINE, CARBO ANIMALIS, COLCHICUM AUTUMNALE BULB, CITRULLUS COLOCYNTHIS FRUIT PULP, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, URTICA URENS
Label structure8 sections

Indications and uses

Uses for temporary relief of symptoms from shellfish and seafood: indigestion, diarrhea, nausea, sinus congestion, headaches, skin irritations, abdominal cramps. Reference image shellfishandseafoodallergyrelief.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 shellfishandseafoodallergyrelief.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Adrenalinum, Belladonna, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrastis canadensis, Kali carbonicum, Lycopodium clavatum, Mercurius solubilis, Pulsatilla, Urtica urens.


Reference image shellfishandseafoodallergyrelief.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 12X, 24X, and LM1 potencies.

Reference image shellfishandseafoodallergyrelief.jpg

Purposes

OTC - PURPOSE SECTION

Uses for temporary relief of symptoms from shellfish and seafood:

  • Indigestion
  • Diarrhea
  • Nausea
  • Sinus Congestion
  • Headaches
  • Skin Irritations
  • Abdominal Cramps
NOTE: For severe allergy symptoms consult your physician.

Reference image shellfishandseafoodallergyrelief.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 shellfishandseafoodallergyrelief.jpg

Warnings

WARNINGS SECTION

Warnings If symptoms persist or worsen, consult a physician.  If pregnant or nursing, take only on advice of healthcare professional.

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

Reference image shellfishandseafoodallergyrelief.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


Reference image shellfishandseafoodallergyrelief.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms from shellfish and seafood: indigestion, diarrhea, nausea, sinus congestion, headaches, skin irritations, abdominal cramps.

Reference image shellfishandseafoodallergyrelief.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


image of labelimage of label

King Bio, Inc.

3 Westside DR

Asheville, NC 28806

Questions?  Call 800.543.3245

www.kingbio.com

Reference image shellfishandseafoodallergyrelief.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357955520122GTIN-13: 0357955520122
EAN-13: 0357955520122
GTIN-12: 357955520122
UPC-A: 357955520122
GTIN storage (14 digits): 00357955520122		shellfishandseafoodallergyrelief.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
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49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6286-22020-01-31C16284748780-19d75b9d0-0157-f424-e053-dadaa90a57ceShellfish and Seafood Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6286-2Shellfish and Seafood Allergy Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6286SHELLFISH AND SEAFOOD ALLERGY RELIEF (ADRENALINUM, BELLADONNA, BROMIUM, CARBO ANIMALIS, COLCHICUM AUTUMNALE, COLOCYNTHIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PULSATILLA, URTICA URENS) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120622_eedd83f1-584e-4a6e-85be-d079895774e6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BROMINEACTIVE INGREDIENTSBV4XY874G1
CARBO ANIMALISACTIVE INGREDIENT279O8I04331
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E61
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BROMINEACTIVE MOIETYSBV4XY874G1
CARBO ANIMALISACTIVE MOIETY279O8I04331
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E61
EPINEPHRINEACTIVE MOIETYYKH834O4BH1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
HISTAMINEACTIVE MOIETY820484N8I31
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
POTASSIUM CATIONACTIVE MOIETY295O53K1521
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-628657955-6286-2

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
EPINEPHRINEYKH834O4BHACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BROMINESBV4XY874GACTIB
CARBO ANIMALIS279O8I0433ACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
651e46b7-3ba8-445b-9e64-67e4c22f8eadeedd83f1-584e-4a6e-85be-d079895774e62012-06-22WarningsExact identifier
spl id: 651e46b7-3ba8-445b-9e64-67e4c22f8ead
spl set id: eedd83f1-584e-4a6e-85be-d079895774e6

Reported adverse events (FAERS/openFDA)#

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