Label: K-OK KIDDIE CALMER- aconitinum, silicea granule
- 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.
Updated August 29, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
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- INACTIVE INGREDIENT
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
Native Remedies, LLC
6531 Park of Commerce Blvd.
Boca Raton, FL 33487
Contains no artificial flavors or artificial colors. No gluten added.
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INGREDIENTS AND APPEARANCE
K-OK KIDDIE CALMER
aconitinum, silicea granule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-049 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_C] in 100 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_C] in 100 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STARCH, CORN (UNII: O8232NY3SJ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCROSE (UNII: C151H8M554) Product Characteristics Color white (White granules) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68703-049-20 20000 mg in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2012 Labeler - Native Remedies, LLC (192014186) Registrant - Native Remedies, LLC (192014186) Establishment Name Address ID/FEI Business Operations King Bio 617901350 api manufacture(68703-049) , manufacture(68703-049)