Label: K-OK KIDDIE CALMER- aconitinum, silicea granule

  • Category: HUMAN OTC DRUG LABEL

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 August 29, 2012

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  • PURPOSE

    Reduces shyness, nervousness and worry in children.

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Aconitinum 6C HPUS, Silicea 6C HPUS.

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for nervousness or shyness in children.

  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a healthcare professional.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: For all ages: Take 5 pilules 2 times daily. Dosage may be increased to 4 times daily if needed. Alternatively, for small babies, crush piulules and sprinkle onto tongue. Special instructions: Take on an empty stomach. Avoid strong mint-flavored candy.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, corn starch, potassium sorbate, sucrose.

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    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

    Contains no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    K-OK KIDDIE CALMER 
    aconitinum, silicea granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_C]  in 100 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White granules) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-049-2020000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2012
    Labeler - Native Remedies, LLC (192014186)
    Registrant - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-049) , manufacture(68703-049)
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