FDA.reportPublic FDA data

Heart Regularity

Manufacturer
King Bio Inc.
Effective date
2012-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:50

Label at a glance#

ProductHeart Regularity
Active ingredientAPOCYNUM CANNABINUM ROOT, BARIUM CARBONATE, SELENICEREUS GRANDIFLORUS STEM, CONVALLARIA MAJALIS, CYPRIPEDIUM PARVIFOLUM ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, NAJA NAJA VENOM, PHOSPHORUS, SPIGELIA ANTHELMIA, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure8 sections

Indications and uses

Uses helps the body regulate nerve impulses to the heart. Reference image heart.jpg

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day Use additionally as needed. Adult Dose 3 pump sprays Children 2-12 years 2 pump sprays Reference image heart.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Apocynum cannabinum, Baryta carbonica, Cactus grandiflorus, Convallaria majalis, Cypripedium pubescens, Gelsemium sempervirens, Glonoinum, Naja tripudians, Phosphorus, Spigelia anthelmia and Spongia tosta.

Reference image heart.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION


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

Reference image heart.jpg

Purpose

OTC - PURPOSE SECTION

  • Uses helps the body regulate nerve impulses to the heart.

Reference image heart.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

Reference image heart.jpg

Warnings

WARNINGS SECTION


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

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

Reference image heart.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image heart.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses helps the body regulate nerve impulses to the heart.

Reference image heart.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of label

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Question? Call 800.543.3245

www.kingbio.com

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
57955-5065-22020-01-31C16284748780-19d75b9d0-dc8a-f424-e053-dadaa90a57ceHeart Regularity

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5065-2Heart Regularity59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5065HEART REGULARITY (APOCYNUM CANNABINUM, BARYTA CARBONICA, CACTUS GRANDIFLORUS, CONVALLARIA MAJALIS, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, GLONOINUM, NAJA TRIPUDIANS, PHOSPHORUS, SPIGELIA ANTHELMIA AND SPONGIA TOSTA) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120621_2f6db269-ac42-45ff-9fec-f85a62a8841d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APOCYNUM CANNABINUM ROOTACTIVE INGREDIENT2F92409L9Z1
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ81
CONVALLARIA MAJALISACTIVE INGREDIENTQHH4HVF5QE1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE INGREDIENT21Y9GZ1LZA1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
NAJA NAJA VENOMACTIVE INGREDIENTZZ4AG7L7VM1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS31
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
SELENICEREUS GRANDIFLORUS STEMACTIVE INGREDIENT7114SV0MYK1
SPIGELIA ANTHELMIAACTIVE INGREDIENTWYT05213GE1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID1
APOCYNUM CANNABINUM ROOTACTIVE MOIETY2F92409L9Z1
BARIUM CATIONACTIVE MOIETYV645272HLN1
CONVALLARIA MAJALISACTIVE MOIETYQHH4HVF5QE1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE MOIETY21Y9GZ1LZA1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
NAJA NAJA VENOMACTIVE MOIETYZZ4AG7L7VM1
NITROGLYCERINACTIVE MOIETYG59M7S0WS31
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
SELENICEREUS GRANDIFLORUS STEMACTIVE MOIETY7114SV0MYK1
SPIGELIA ANTHELMIAACTIVE MOIETYWYT05213GE1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-506557955-5065-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
APOCYNUM CANNABINUM ROOT2F92409L9ZACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITROGLYCERING59M7S0WS3ACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
PHOSPHORUS27YLU75U4WACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
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
a6cad210-eab5-42b9-a990-f00d408d367e2f6db269-ac42-45ff-9fec-f85a62a8841d2012-06-21WarningsExact identifier
spl id: a6cad210-eab5-42b9-a990-f00d408d367e
spl set id: 2f6db269-ac42-45ff-9fec-f85a62a8841d

Reported adverse events (FAERS/openFDA)#

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