The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Nativeremedies Tic Tamer (NDC 68703-398). 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 hpus active ingredient, uses*, warnings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HPUS Active Ingredients: Equal volumes of each ingredient: Chamomilla 12C, Cina 30C, Hyoscyamus 30C, Zinc met 30C.
The letters HPUS indicate that the components in this product are offically monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy to control involuntary tics and jerking movements.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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: Dilute drops in a small amount of water and sip slowly. Alternatively, drop directly into the mouth 3-5 times daily until symptoms improve. Adults & Children 12+: 0.50 mL. Children under 12: 0.25 mL.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive Ingredients: USP grain alcohol (20% by volume), purified water.
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Controls involuntary tics & jerking.
* Please review the disclaimer below.
