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

4 Kids Canker Sore Soothing Dots by

Drug Labeling and Warnings

4 Kids Canker Sore Soothing Dots by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WARNINGS

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.

INACTIVE INGREDIENT

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PURPOSE

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/21/2017

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3342) , pack(54973-3342) , label(54973-3342)