The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Nativeremedies Anger-soothe (NDC 68703-392). 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 ingrediients, 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 in a 6C potency: Chamomilla, Lycopodium, Nux vomica.
The letters HPUS indicate that the components in this product are offically monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy soothes feelings of anger and prevents temper outbursts.
*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: For all ages: Mix 0.50 mL in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into the mouth. Use 3-5 times daily as needed until symptoms improve.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive Ingredients: Purified water, USP grain alcohol (20% by volume).
Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Conrtol Center right away.
If pregnant or breastfeeding, ask a health professional before use.
Reduces angry feelings & emotional outbursts.
* Please review the disclaimer below.
