{"active_ingredient":["Active ingredients Purpose Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated) occasional sleeplessness Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated) anxiousness, worry Kali Phosphoricum 3X HPUS wakefulness, occasional sleeplessness, nervousness \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States."],"active_ingredient_table":["
"],"do_not_use":["Do not use more than directed."],"dosage_and_administration":["Directions Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary."],"effective_time":"20221214","id":"efce1ee2-5859-4587-e053-2995a90a3bba","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose."],"indications_and_usage":["Uses ■ Temporarily relieves symptoms of occasional sleeplessness due to: ■ anxiousness ■ worry ■ wakefulness ■ nervousness"],"keep_out_of_reach_of_children":["Keep this and all medications out of the reach of children."],"openfda":{"brand_name":["Sleep"],"generic_name":["HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC"],"is_original_packager":[true],"manufacturer_name":["Hyland's Inc."],"package_ndc":["54973-3206-1"],"product_ndc":["54973-3206"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["efce1ee2-5859-4587-e053-2995a90a3bba"],"spl_set_id":["8ad9775f-367c-45c9-890d-69a3734965f1"],"substance_name":["HYOSCYAMUS NIGER","STRYCHNOS IGNATII SEED","POTASSIUM PHOSPHATE, DIBASIC"],"unii":["4WRK2153H3","1NM3M2487K","CI71S98N1Z"],"upc":["0354973320611"]},"other_safety_information":["Other information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing."],"overdosage":["In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton HOMEOPATHIC NDC 54973-3206-1 SINCE 1903 Hyland's Sleep* NATURAL ACTIVE INGREDIENTS GENTLE ON YOU Relieves Occasional Sleeplessness Due to Nervousness or Worry 100 QUICK-DISSOLVING TABLETS * SEE NOTE ON SIDE PANEL BELOW DRUG FACTS NATURAL RELIEF Carton"],"pregnancy_or_breast_feeding":["As with any drug, ask a doctor before use if pregnant or breast-feeding."],"purpose":["Relieves Occasional Sleeplessness Due to Nervousness or Worry"],"questions":["Questions or comments? (800) 624-9659"],"recent_major_changes":["Indications and Usage Temporarily relieves symptoms of occasional sleeplessness due to: anxiousness worry wakefulness nervousness","Dosage and Administration Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary."],"set_id":"8ad9775f-367c-45c9-890d-69a3734965f1","spl_product_data_elements":["Sleep HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC ACACIA LACTOSE HYOSCYAMUS NIGER HYOSCYAMUS NIGER STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated) occasional sleeplessness Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated) anxiousness, worry Kali Phosphoricum 3X HPUS wakefulness, occasional sleeplessness, nervousness \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.","Drug Facts (continued) Directions Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["
"],"stop_use":["Stop use and consult a physician if symptoms persist for more than 7 days or worsen."],"version":"4","warnings":["Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Stop use and consult a physician if symptoms persist for more than 7 days or worsen. Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659."]}