Label: K-OK KIDDIE CALMER- silicea , aconite , sucrose 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 July 15, 2010

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

View All Sections
  • DESCRIPTION

    Relieves shyness, nervousness and worry in children

  • INDICATIONS & USAGE

    Indications:  Homeopathic remedy for nervousness or shyness in children.

  • DOSAGE & ADMINISTRATION

    Dosage: Dissolve 5 pilules twice a day in a clean mouth. Dosage may be increased to 3-4 times daily if needed.

  • GENERAL PRECAUTIONS

    Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.

  • ACTIVE INGREDIENT

    Ingredients: Each dose contains equal parts of Silicea (6C) (HPUS), Aconite (6C) (HPUS)

  • INACTIVE INGREDIENT

    Sucrose inactive ingredient)

  • PREGNANCY

    If pregnant or breastfeeding, ask a health professional before use. 

  • USER SAFETY WARNINGS

    Contains no gluten, artificial flavors, colors or preservatives.  Safe for all ages and during pregnancy.

  • INFORMATION FOR PATIENTS

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by

    Native Remedies, LLC

    6531 Park of Commerce Blvd. 

    Suite 160

    Boca Raton, FL 33487

    Phone: +1.877.289.1235

    International: +1.561.999.8857

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    K-OK KIDDIE CALMER  
    silicea , aconite , sucrose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white lactose tablets) Scoreno score
    ShapeROUND (round white tablets) Size5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-102-10125 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/15/2010
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.last567284153manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!