{"active_ingredient":["Active ingredients** (in each 1 mL vial) Chamomilla 9C HPUS (0.17 mL) Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids) Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids) Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide) Passiflora incarnata 3C HPUS (0.17 mL) Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 mg atropine alkaloids) The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."],"do_not_use":["Do not use if your child has a known allergy to any ingredient in this product."],"dosage_and_administration":["Children 3 years of age and older: Give 1 dose at bedtime, and again during the night if needed for up to a total of 2 doses per night. Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. Squeeze entire contents into mouth."],"effective_time":"20240809","id":"1f452ffb-58f3-8ade-e063-6394a90ad0c8","inactive_ingredient":["alcohol, purified water,"],"indications_and_usage":["Uses* temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as: restless sleep intermittent awakening irritability nightmares night terrors reduces the time to fall asleep if your child has difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["SleepCalm Kids"],"generic_name":["MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM"],"is_original_packager":[true],"manufacturer_name":["Boiron"],"package_ndc":["0220-9309-09","0220-9309-07"],"product_ndc":["0220-9309"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["1f452ffb-58f3-8ade-e063-6394a90ad0c8"],"spl_set_id":["aef7b774-355a-3fb8-e053-2a95a90a268c"],"substance_name":["DATURA STRAMONIUM","POTASSIUM BROMIDE","PASSIFLORA INCARNATA FLOWERING TOP","MATRICARIA CHAMOMILLA WHOLE","GELSEMIUM SEMPERVIRENS ROOT","HYOSCYAMUS NIGER"],"unii":["G6W4F0V8Z3","OSD78555ZM","CLF5YFS11O","G0R4UBI2ZZ","639KR60Q1Q","4WRK2153H3"]},"package_label_principal_display_panel":["label label label label label"],"purpose":["Purpose* Chamomilla 9C HPUS ... Relieves restlessness, irritability, and crying during sleep Gelsemium sempervirens 9C HPUS ... Relieves sleeplessness due to apprehension Hyoscyamus niger 9C HPUS ... Relieves irritability and restless sleep associated with nervousness Kali bromatum 9C HPUS ... Relieves irritability and restless sleep with night terrors Passiflora incarnata 3C HPUS ... Relieves occasional restless sleep Starmonium 9C HPUS ... Relieves restless sleep with intermittent awakening, nightmares and night terrors"],"questions":["BoironUSA.com Info@boiron.com 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073 Made in France"],"set_id":"aef7b774-355a-3fb8-e053-2a95a90a268c","spl_product_data_elements":["SleepCalm Kids MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM DATURA STRAMONIUM DATURA STRAMONIUM POTASSIUM BROMIDE BROMIDE ION PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP WATER ALCOHOL MATRICARIA CHAMOMILLA WHOLE MATRICARIA CHAMOMILLA WHOLE GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT HYOSCYAMUS NIGER HYOSCYAMUS NIGER"],"spl_unclassified_section":["do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact do not refrigerate or freeze after opening the foil pouch: store unused vials in the foil pouch for no longer than 3 months after opening the vial: the product must be used immediately after administering: discard vial do not reuse contains 0.0015% alcohol Calms Restless Sleep* Kids Sleep Aid* Melatonin Free 15 pre-measured liquid doses 5 pre-measured liquid doses 0.34 fl oz (1 mL) each 99.99% alcohol-free Fall Asleep, Stay Asleep *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 and use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness."],"version":"6","warnings":[""]}