K-OK Kiddie Calmer: Homeopathic Product Information

K-OK KIDDIE CALMER — aconitum napellus and silicon dioxide granule
Native Remedies, LLC

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.

Reduces shyness, nervousness and worry in children.

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

Uses: Homeopathic remedy for nervousness or shyness in children.

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

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

Keep this and all medication out of reach of children.

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

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

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.

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

Bottle Label
(click image for full-size original)

K-OK KIDDIE CALMER
aconitinum, silicea granule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_C] in 100 mg
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 6 [hp_C] in 100 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
STARCH, CORN
POTASSIUM SORBATE
SUCROSE
Product Characteristics
Color white (White granules) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68703-049-20 20000 mg in 1 BOTTLE, GLASS None
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 Operations
King Bio 617901350 api manufacture (68703-049), manufacture (68703-049)

Revised: 08/2012 Native Remedies, LLC

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