The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Sleepy Jr (NDC 68703-316). 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: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C.
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seals intact.
Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Relieves occasional sleeplessness & restlessness in toddler and children.
* Please review the disclaimer below.
