FDA.reportPublic FDA data

4 Kids Canker Sore Soothing Dots

Manufacturer
Hyland's Inc.
Effective date
2022-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:47:37

Label at a glance#

Product4 Kids Canker Sore Soothing Dots
Active ingredientSILVER NITRATE, ECHINACEA, UNSPECIFIED, POTASSIUM CHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of sores and ulcers in mouth,discomfort of gums or tongue due to canker sores.

Dosage and administration

Children 2 years to under 6 years of age: dissolve 1 tablet on tongue every 15 minutes for 4 doses, then hourly until relieved. Children 6 years to under 12 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. Adults and Children 12 years and over: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. Hyland’s Canker Sore Soothing Dot...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Argentum Nitricum 6X HPUS

discomfort of gums or tongue due to canker sores

Echinacea 6X HPUS

mouth sores, discomfort of gums or tongue due to canker sores

Kali Muriaticum 6X HPUS

sores and ulcers in mouth

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of sores and ulcers in mouth,discomfort of gums or tongue due to canker sores.

WARNINGS SECTION

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use • more than directed • if your child has a known allergy to any ingredient in this product.

Consult a physician if: • symptoms persist for more than 72 hours or worsen

• swelling increases, rash or fever develops • irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Do not use if imprinted tamper band is broken or missing.

In case of emergency

SPL UNCLASSIFIED SECTION

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Children 2 years to under 6 years of age: dissolve 1 tablet on tongue every 15 minutes for 4 doses, then hourly until relieved.

Children 6 years to under 12 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. Hyland’s Canker Sore Soothing Dots Relief Tablets are very soft and will dissolve instantly in the mouth.

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

OTC - PURPOSE SECTION

Temporarily relieves the symptoms of sores and ulcers in mouth, discomfort of gums or tongue due to canker sores.

Principal Display Panel - 50 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

Natural

Relief

NDC 54973-3342-1

HOMEOPATHIC

SINCE 1903

Hyland's ®

4Kids

Canker Sore*

Soothing Dots

RELIEF TABLETS

Benzocaine Free

No Burning or Numbing

For Braces,

Sores & Irritations

50 QUICK-DISSOLVING

TABLETS

ACTUAL SIZE

194 MG

SAFE &

EFFECTIVE

Carton1Carton1

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
54973-334254973-3342-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILVER NITRATE95IT3W8JZEACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB

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
08132dd1-5d5f-d380-e063-6394a90a4aeb5b5cb641-234f-76b5-e053-2991aa0abbcd2023-10-19WarningsExact identifier
spl set id: 5b5cb641-234f-76b5-e053-2991aa0abbcd

Reported adverse events (FAERS/openFDA)#

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