The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Triple Complex Sleep Tonic (NDC 68703-388). 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 ingredients, *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 an 8X potency: Calc phos, Calc sulph, Mag phos.
The letters HPUS indicated that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy for peaceful slumber & sleep routine.
*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 or childern. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions: Mix in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into mouth. For all ages: Acute: Take 0.25-0.50 mL every hour, up to 10 doses, until symptoms improve. Chronic: Take 0.25-0.50 mL 3 times daily.
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, sucrose.
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.
If pregnant or breastfeeding, ask a health professional before use.
Relieves sleeplessness in all ages
* Please review the disclaimer below.
