{"active_ingredient":["Active ingredients** (in each pellet) Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids) Nux moschata 4C HPUS (0.11 mg) Passiflora incarnata 3X HPUS (0.11 mg) Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids) 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 Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue at bedtime. Children under 12 years of age: Ask a doctor."],"effective_time":"20240423","id":"16c77587-39d7-31cf-e063-6294a90a7f22","inactive_ingredient":["lactose, sucrose"],"indications_and_usage":["Uses* temporarily relieves: occasional sleeplessness restless sleep intermittent awakening helps reduce difficulty falling asleep due to: nervousness worries"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["SleepCalm"],"generic_name":["HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM"],"is_original_packager":[true],"manufacturer_name":["Boiron"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0016962","M0006342","M0008672","M0516536"],"package_ndc":["0220-9311-41","0220-9311-42"],"pharm_class_cs":["Allergens [CS]","Plant Proteins [CS]","Dietary Proteins [CS]","Food Additives [CS]","Seed Storage Proteins [CS]"],"pharm_class_epc":["Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["0220-9311"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["16c77587-39d7-31cf-e063-6294a90a7f22"],"spl_set_id":["dda7a51d-7c2c-67f4-e053-2a95a90a8e72"],"substance_name":["HYOSCYAMUS NIGER","DATURA STRAMONIUM","PASSIFLORA INCARNATA TOP","NUTMEG"],"unii":["4WRK2153H3","G6W4F0V8Z3","CLF5YFS11O","AEE24M3MQ9"]},"package_label_principal_display_panel":["label Label label label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Hyoscyamus niger 3C HPUS (0.11 mg) ... Relieves restless sleep associated with nervousness Nux moschata 4C HPUS (0.11 mg) ... Relieves restless sleep Passiflora incarnata 3X HPUS (0.11 mg) ... Relieves sleeplessness associated with worries and exhaustion Stramonium 6X HPUS (0.11 mg) ... Relieves sleeplessness with intermittent awakening"],"questions":["BoironUSA.com Info@Boiron.Com 1-800-264-7661 Made in France Distributed by Boiron, Inc. Newtown Square, PA 19073"],"set_id":"dda7a51d-7c2c-67f4-e053-2a95a90a8e72","spl_product_data_elements":["SleepCalm HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM LACTOSE, UNSPECIFIED FORM HYOSCYAMUS NIGER HYOSCYAMUS NIGER DATURA STRAMONIUM DATURA STRAMONIUM PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP SUCROSE NUTMEG NUTMEG"],"spl_unclassified_section":["Melatonin-Free Sleep Relief* do not use if glued carton end flaps are open or if pellet dispenser seal is broken contains 0.25 g of sugar per dose Calms Restless Mind* No Known Drug Interactions 2 PORTABLE TUBES APPROX. 80 PELLETS EACH TOTAL 160 PELLETS Tube - Contains approx. 80 pellets, 3.8g, (0.13 oz) Tube - Do not use if pellet dispenser seal is broken. Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details."],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness."],"version":"3","warnings":[""]}