Otc - Purpose
Reduces shyness, nervousness and worry in children.
K-ok Kiddie Calmer
FDA Label NDC 68703-049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Native Remedies, Llc for the product K-ok Kiddie Calmer (NDC 68703-049). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - 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.
Package Label.Principal Display Panel
Bottle Label (Kok001)
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