The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Good Night Sleep (NDC 68703-381). 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 10X, 15X, 30X potencies: Aconitum nap, Aesculus hipp, flos, Avena, Cocculus, coffea cruda, Hyoscyamus, Ignatia, Passiflora, Pulsatilla nutt, Staphysagrai, Valeriana.
Uses*: Temporarily relieves symptoms of occasional sleeplessness.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings:
If symptoms persist or worsen, consulta 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: Intially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and children 12+: 3 sprays, 3 times per day. Children 2-12: 2 sprays, 3 times per day. Use additionally as needed, up to 6 times per day.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. use only if safety seal is intact.
Inactive Ingredients: Ethyl alcohol, glycerin, purified water.
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Temporarily relieves symptoms of occasional sleeplessness*
*claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
* Please review the disclaimer below.
