FDA.reportPublic FDA data

Kids Upset Tummy Relief

Manufacturer
Similasan Corporation
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:31

Label at a glance#

ProductKids Upset Tummy Relief
Active ingredientARSENIC TRIOXIDE, IPECAC, MERCURIC CHLORIDE, PODOPHYLLUM
Label structure16 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • Nausea • Stomach Pain • Diarrhea • Bloating • Cramps

Dosage and administration

Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Kids Upset Tummy Relief

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arsenicum album 6X

Purpose

OTC - PURPOSE SECTION

diarrhea, nausea, stomach cramps, bloating

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ipecacuanha (Ipecac) 6X

Purpose

OTC - PURPOSE SECTION

nausea, vomiting

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mercurius corrosivus 6X

Purpose

OTC - PURPOSE SECTION

stomach pain

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Podophyllum peltatum (Mayapple) 6X

Purpose

OTC - PURPOSE SECTION

bloating, nausea, cramps

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• Nausea
• Stomach Pain
• Diarrhea
• Bloating
• Cramps

Warnings

WARNINGS SECTION

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• Do not exceed recommended dosage.

• Not intended for children under 2.

• Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

symptoms worsen or persist for more than 72 hours

Directions Adults and Children ages 2 and older:

DOSAGE & ADMINISTRATION SECTION

Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

Other Information

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-607-30
Similasan
Kids Upset
Tummy
Relief
Mayapple Actives
60 Dissolvable Tablets

PRINCIPAL DISPLAY PANEL NDC 59262-607-30 Similasan Kids Upset Tummy Relief Mayapple Actives 60 Dissolvable TabletsPRINCIPAL DISPLAY PANEL NDC 59262-607-30 Similasan Kids Upset Tummy Relief Mayapple Actives 60 Dissolvable Tablets

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-607-302021-01-29C16284748780-1ba0f9c33-0d7b-a910-e053-dadaa90a0b85Kids Upset Tummy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-607-30Kids Upset Tummy Relief60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-607KIDS UPSET TUMMY RELIEF (ARSENIC TRIOXIDE, IPECAC, MERCURIC CHLORIDE AND PODOPHYLLUM) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]1Legacy NDC, 1 package rows20170201_2a9c0cc0-ec4b-4353-b038-a737e520aa8a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-60759262-607-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
IPECAC62I3C8233LACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
PODOPHYLLUM2S713A4VP3ACTIB
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT

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
8e3e6f64-21d9-40fb-9a96-82538cf46bb62a9c0cc0-ec4b-4353-b038-a737e520aa8a2016-12-12WarningsExact identifier
spl id: 8e3e6f64-21d9-40fb-9a96-82538cf46bb6
spl set id: 2a9c0cc0-ec4b-4353-b038-a737e520aa8a

Reported adverse events (FAERS/openFDA)#

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