{"active_ingredient":["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."],"dosage_and_administration":["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."],"effective_time":"20241203","id":"28687c5e-f464-d9eb-e063-6394a90a9427","inactive_ingredient":["Inactive Ingredients Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose."],"indications_and_usage":["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."],"keep_out_of_reach_of_children":["Keep this and all medication out of reach of children."],"openfda":{"brand_name":["Sleepy Jr"],"generic_name":["CHAMOMILLA, CINA, CINCHONA, COFFEA CRUDA, NUX VOM"],"is_original_packager":[true],"manufacturer_name":["Silver Star Brands"],"nui":["N0000185375","N0000175629","N0000184306","N0000185001","M0000728","M0016962","M0516536"],"package_ndc":["68703-316-30"],"pharm_class_cs":["Allergens [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]"],"pharm_class_epc":["Non-Standardized Plant Allergenic Extract [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["68703-316"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["28687c5e-f464-d9eb-e063-6394a90a9427"],"spl_set_id":["81a22c7c-69a5-ea2a-e053-2991aa0a1a5c"],"substance_name":["STRYCHNOS NUX-VOMICA SEED","MATRICARIA CHAMOMILLA FLOWERING TOP OIL","ARTEMISIA CINA FLOWER","COFFEA ARABICA FRUIT","CINCHONA OFFICINALIS BARK"],"unii":["269XH13919","SA8AR2W4ER","28M1820ACT","HOX6BEK27Q","S003A158SB"]},"other_safety_information":["Contains no artificial flavors or colorants. No gluten added. Tamper resistant for your protection. Use only if safety seals intact."],"package_label_principal_display_panel":["Sleepy Jr"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Relieves occasional sleeplessness & restlessness in toddler and children."],"set_id":"81a22c7c-69a5-ea2a-e053-2991aa0a1a5c","spl_product_data_elements":["Sleepy Jr Chamomilla, Cina, Cinchona, Coffea cruda, Nux vom STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED WATER LACTOSE, UNSPECIFIED FORM ANHYDROUS LACTOSE MATRICARIA CHAMOMILLA FLOWERING TOP OIL MATRICARIA CHAMOMILLA FLOWERING TOP OIL ACACIA MAGNESIUM STEARATE ARTEMISIA CINA FLOWER ARTEMISIA CINA FLOWER COFFEA ARABICA FRUIT COFFEA ARABICA FRUIT CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK SUCROSE Round Lactose Tablets Round White Lactose Tablets None"],"version":"3","warnings":["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."]}