4 KIDS CANKER SORE SOOTHING DOTS- silver nitrate,echinacea, unspecified and potassium chloride tablet
Hyland's Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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4 Kids Canker Sore Soothing Dots

Drug Facts

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

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

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.

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.

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

In case of emergency

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

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.

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

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

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

Carton1

4 KIDS CANKER SORE SOOTHING DOTS
silver nitrate,echinacea, unspecified and potassium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3342
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	6 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X]
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (White to Off-White)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3342-1	1 in 1 CARTON	08/21/2017
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/21/2017	10/19/2023

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3342) , pack(54973-3342) , label(54973-3342)

Revised: 10/2023

Document Id: 08132dd1-5d5f-d380-e063-6394a90a4aeb

Set id: 5b5cb641-234f-76b5-e053-2991aa0abbcd

Version: 3

Effective Time: 20231019

Hyland's Inc.