FDA.reportPublic FDA data

Kids Cough Relief

Manufacturer
King Bio Inc
Effective date
2018-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:17

Label at a glance#

ProductKids Cough Relief
Active ingredientACONITUM NAPELLUS, BROMINE, PROTORTONIA CACTI, CORALLIUM RUBRUM EXOSKELETON, COPPER, DROSERA ROTUNDIFOLIA, CALCIUM SULFIDE, IODINE, MEPHITIS MEPHITIS ANAL GLAND FLUID, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure9 sections

Indications and uses

for temporary relief of minor cough symptoms. Note: A persistent cough may be a sign of a serios condition. If cough persist for more than 7 days, tends to recur, or if symptoms change, consult a doctor.

Dosage and administration

Initially, depress pump until primed Spray one dose directly into mouth Ages 12 and Up: 3 sprays 3 times per day Ages 2-12: 2 sprays 3 times per day

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap, Bromium, Coccus, Coallium, Cuprum met, Drosera, Hepar sulph calc, Iodium, Mephitis, Spongia.

Equal volumes of each ingredient in 10X, 30C, 1LM potencies.

​Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor cough symptoms. Note: A persistent cough may be a sign of a serios condition. If cough persist for more than 7 days, tends to recur, or if symptoms change, consult a doctor.

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bio-Energetically Enhanced pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

​Warnings

WARNINGS SECTION

​Stop use and ask a doctor, ​if symptoms persist or worsen.

​If pregnant or breast-feeding, ​ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.

​Directions

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed

Spray one dose directly into mouth

Ages 12 and Up: 3 sprays 3 times per day

Ages 2-12: 2 sprays 3 times per day

OTC - PURPOSE SECTION

​Uses ​for temporary relief of minor cough symptoms.

​Other Information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0451-22020-01-31C16284748780-19d75b9d1-1971-f424-e053-dadaa90a57ceKids Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0451-2Kids Cough Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0451KIDS COUGH RELIEF (ACONITUM NAP, BROMIUM, COCCUS, COALLIUM, CUPRUM MET, DROSERA, HEPAR SULPH CALC, IODIUM, MEPHITIS, SPONGIA) LIQUID [KING BIO INC]1Legacy NDC, 1 package rows20180314_aa347172-071b-4058-ac3c-d59c714210a6.zip

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
57955-045157955-0451-2

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
ACONITUM NAPELLUSU0NQ8555JDACTIB
BROMINESBV4XY874GACTIB
PROTORTONIA CACTILZB7TFX1LTACTIB
CORALLIUM RUBRUM EXOSKELETON2CA71K0DLEACTIB
COPPER789U1901C5ACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
IODINE9679TC07X4ACTIB
MEPHITIS MEPHITIS ANAL GLAND FLUID3BN57UN4USACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
WATER059QF0KO0RIACT
CARYA OVATA BARKX765CF609LIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
POLYEPSILON-LYSINE (4000 MW)WB0M8X4TWRIACT
REBAUDIOSIDE AB3FUD0528FIACT

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
c68f3471-67dc-4c47-8d10-a28ada8cd7b5aa347172-071b-4058-ac3c-d59c714210a62018-03-14WarningsExact identifier
spl id: c68f3471-67dc-4c47-8d10-a28ada8cd7b5
spl set id: aa347172-071b-4058-ac3c-d59c714210a6

Reported adverse events (FAERS/openFDA)#

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