{"active_ingredient":["Active Ingredients** (in each tablet) Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids) Nux moschata 4C HPUS (0.63 mg) Passiflora incarnata 3X HPUS (0.63 mg) Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids) The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."],"ask_doctor":["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."],"dosage_and_administration":["Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime. Children under 12 of age: Ask a doctor."],"effective_time":"20250321","id":"30dd55c3-2031-ce2f-e063-6294a90a3f1f","inactive_ingredient":["croscarmellose sodium, lactose, magnesium stearate"],"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 TOP, DATURA STRAMONIUM"],"is_original_packager":[true],"manufacturer_name":["Laboratoires Boiron"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0016962","M0006342","M0008672","M0516536"],"package_ndc":["0220-9310-04","0220-9310-29","0220-9310-91","0220-9310-92"],"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":["0220-9310"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["30dd55c3-2031-ce2f-e063-6294a90a3f1f"],"spl_set_id":["a1db8417-baea-6914-e053-2a95a90a2fd3"],"substance_name":["HYOSCYAMUS NIGER","PASSIFLORA INCARNATA TOP","DATURA STRAMONIUM","NUTMEG"],"unii":["4WRK2153H3","CLF5YFS11O","G6W4F0V8Z3","AEE24M3MQ9"]},"package_label_principal_display_panel":["1KNE hwb 1hwc LABEL hwe gub 1wd 1120 LABELS"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose* Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening"],"questions":["BoironUSA.com Info@boiron.com 1-800-BOIRON-1 (1-800-264-7661) Made in France Distributed by Boiron, Inc. Newtown Square, PA 19073"],"set_id":"a1db8417-baea-6914-e053-2a95a90a2fd3","spl_product_data_elements":["SleepCalm HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM CROSCARMELLOSE SODIUM HYOSCYAMUS NIGER HYOSCYAMUS NIGER PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP DATURA STRAMONIUM DATURA STRAMONIUM LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE NUTMEG NUTMEG"],"spl_unclassified_section":["do not use if glued carton end flaps are open or if the blister seal is broken store below 86 o F (30 o C) Contains 20 meltaway tablets Contains 60 meltaway tablets Contains 100 meltaway tablets Contains 120 meltaway tablets *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. Calms Restless Mind* No Known Drug Interactions Non-habit forming No artificial sweetners or flavors Gluten-free Melatonin-Free Sleep Relief*"],"version":"6","warnings":[""]}