FDA.reportPublic FDA data

Kids Tummy Aches

Manufacturer
King Bio Inc
Effective date
2018-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:17

Label at a glance#

ProductKids Tummy Aches
Active ingredientSILVER NITRATE, BRYONIA ALBA ROOT, ANAMIRTA COCCULUS SEED, NITROGLYCERIN, SKIM MILK, KEROSENE, DELPHINIUM STAPHISAGRIA SEED, TOBACCO LEAF
Label structure9 sections

Indications and uses

for temporary relief of symptoms: nausea vomiting belching gas bloating aversion to food stomach cramps headaches empty feeling in stomach.

Dosage and administration

Initially, depress pump until primed Spray one dose directly into mouth 2 months to 2 years: 1 spray 3 times per day 2 to 12 years: 2 sprays 3 times per day Adults 12 years and older: 3 sprays 3 times per day

Label contents#

Full prescribing information#

​HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Argentum nitricum

Bryonia

Cocculus indicus

Glonoinum

Lac defloratum

Petroleum

Staphysagria

Tabacum

​Uses

INDICATIONS & USAGE SECTION

for temporary relief of symptoms:

  • nausea
  • vomiting
  • belching
  • gas
  • bloating
  • aversion to food
  • stomach cramps
  • headaches
  • empty feeling in stomach.

​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

2 months to 2 years: 1 spray 3 times per day

2 to 12 years: 2 sprays 3 times per day

Adults 12 years and older: 3 sprays 3 times per day

​Other Information

OTHER SAFETY INFORMATION

  • This product is intended to compliment, not replace, standard medical care
  • Tamper resistant for your protection. Use only if safety seal is intact.

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bio-Energeticall Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

​Purpose

OTC - PURPOSE SECTION

Argentum nitricum.......belching, nausea, vomiting

Bryonia.......................abdominal discomforts, nausea

Cocculus indicus..........stomach cramps, aversion to food

Glonoinum..................empty feeling in stomach

Lac defloratum............aversion to milk, headache

Petroleum...................nausea, gas

Staphysagria...............bloating, flatulence

Tabacum....................vomiting, gastric colic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product 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
57955-0460-22020-01-31C16284748780-19d75b9d1-19bf-f424-e053-dadaa90a57ceKids Tummy Aches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0460-2Kids Tummy Aches1 in 1 CARTONLIQUID11
57955-0460-2Kids Tummy Aches59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0460KIDS TUMMY ACHES (ARGENTUM NITRICUM, BRYONIA, COCCULUS INDICUS, GLONOINUM, LAC DEFLORATUM, PETROLEUM, STAPHYSAGRIA, TABACUM) LIQUID [KING BIO INC]1Legacy NDC, 2 package rows20180322_e7664500-448b-4cd2-ade1-f5a5c03aa770.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-046057955-0460-2

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
SILVER NITRATE95IT3W8JZEACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
NITROGLYCERING59M7S0WS3ACTIB
SKIM MILK6A001Y4M5AACTIB
KEROSENE1C89KKC04EACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
TOBACCO LEAF6YR2608RSUACTIB
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
d1c06068-626b-48e2-9937-b0ca29da9fcde7664500-448b-4cd2-ade1-f5a5c03aa7702018-03-22WarningsExact identifier
spl id: d1c06068-626b-48e2-9937-b0ca29da9fcd
spl set id: e7664500-448b-4cd2-ade1-f5a5c03aa770

Reported adverse events (FAERS/openFDA)#

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