K-OK KIDDIE CALMER- aconitinum, silicea granule

K-OK Kiddie Calmer by

Drug Labeling and Warnings

K-OK Kiddie Calmer by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)