FDA Label for Sleepy Jr
View Indications, Usage & Precautions
Sleepy Jr Product Label
The following document was submitted to the FDA by the labeler of this product Silver Star Brands. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Hpus Active Ingredients
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*
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
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
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.
Other Safety Information
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seals intact.
Inactive Ingredients
Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Purpose
Relieves occasional sleeplessness & restlessness in toddler and children.
* Please review the disclaimer below.