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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated October 12, 2017

If you are a consumer or patient please visit this version.

  • 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

    Carton1

  • INGREDIENTS AND APPEARANCE
    4 KIDS CANKER SORE SOOTHING DOTS 
    silver nitrate,echinacea, unspecified and potassium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3342
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_X]
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3342-11 in 1 CARTON08/21/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3342) , pack(54973-3342) , label(54973-3342)