FDA.reportPublic FDA data

Childrens Fever Reliever

Manufacturer
King Bio Inc.
Effective date
2012-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:49

Label at a glance#

ProductChildrens Fever Reliever
Active ingredientACETIC ACID, ACONITUM NAPELLUS, HORSE CHESTNUT, AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SAMBUCUS NIGRA FLOWERING TOP, SULFUR, VERATRUM VIRIDE ROOT
Label structure8 sections

Indications and uses

Uses for fast relief of symptoms: fever, sweats, chills, shakes, aches, vomiting, restlessness, lethargy, nausea, muscular soreness, fears, irritability and oversensitivity. Reference image childrens fever.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 childrens fever.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur and Veratrum viride.

Reference image childrens fever.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 childrens fever.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 childrens fever.jpg

Purpose

OTC - PURPOSE SECTION

Uses for fast relief of symptoms:

  • fever
  • sweats
  • chills
  • shakes
  • aches
  • vomiting
  • restlessness
  • lethargy
  • nausea
  • muscular soreness
  • fears
  • irritability
  • oversensitivity
Reference image childrens fever.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 childrens fever.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image childrens fever.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for fast relief of symptoms: fever, sweats, chills, shakes, aches, vomiting, restlessness, lethargy, nausea, muscular soreness, fears, irritability and oversensitivity.

Reference image childrens fever.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of label

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5159-22020-01-31C16284748780-19d75b9d0-58a5-f424-e053-dadaa90a57ceChildren's Fever Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5159-2Childrens Fever Reliever59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5159CHILDRENS FEVER RELIEVER (ACETICUM ACIDUM, ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, AGARICUS MUSCARIUS, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CHAMOMILLA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, PULSATILLA, RHUS TOXICODENDRON, SAMBUCUS NIGRA, SULPHUR AND VERATRUM VIRIDE.) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120619_cb039dc7-91ef-4b30-8d0e-6102e026f374.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063P1
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE INGREDIENTDIF093I0371
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
HORSE CHESTNUTACTIVE INGREDIENT3C18L6RJAZ1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18U1
SULFURACTIVE INGREDIENT70FD1KFU701
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
VERATRUM VIRIDE ROOTACTIVE INGREDIENT197B3Q7T5Q1
ACETIC ACIDACTIVE MOIETYQ40Q9N063P1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE MOIETYDIF093I0371
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
FERRIC CATIONACTIVE MOIETY91O4LML6111
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
HORSE CHESTNUTACTIVE MOIETY3C18L6RJAZ1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18U1
SULFURACTIVE MOIETY70FD1KFU701
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
VERATRUM VIRIDE ROOTACTIVE MOIETY197B3Q7T5Q1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
57955-515957955-5159-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETIC ACIDQ40Q9N063PACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYDIF093I037ACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SULFUR70FD1KFU70ACTIB
VERATRUM VIRIDE ROOT197B3Q7T5QACTIB
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
a7c67c4d-cb4b-4897-8217-8ca8b693a8e2cb039dc7-91ef-4b30-8d0e-6102e026f3742012-06-19WarningsExact identifier
spl id: a7c67c4d-cb4b-4897-8217-8ca8b693a8e2
spl set id: cb039dc7-91ef-4b30-8d0e-6102e026f374

Reported adverse events (FAERS/openFDA)#

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