{"active_ingredient":["Active ingredients Purpose \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness, fussiness, and agitation Coffea Cruda 6X HPUS irritability Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated) restless sleep Lycopodium 30X HPUS unpredictable, irregular sleep Natrum Muriaticum 6X HPUS crying, irritability Platinum Metallicum 30X HPUS causeless crying, waking at night Pulsatilla 6X HPUS cries easily, inconsolable Sulphur 12X HPUS crying, restlessness, irritability"],"active_ingredient_table":["<table width=\"85%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"2\"><content styleCode=\"italics\">&quot;HPUS&quot; indicates that the active ingredients are in the official Homeopathic Pharmacop&#x153;ia of the United States.</content></td></tr></tfoot><tbody><tr><td>Chamomilla 6X HPUS</td><td>occasional sleeplessness, fussiness, and agitation</td></tr><tr><td>Coffea Cruda 6X HPUS</td><td>irritability</td></tr><tr><td>Ignatia Amara 30X HPUS  (less than 0.0000000000001% Alkaloids, calculated) </td><td>restless sleep</td></tr><tr><td>Lycopodium 30X HPUS</td><td>unpredictable, irregular sleep</td></tr><tr><td>Natrum Muriaticum 6X HPUS</td><td>crying, irritability</td></tr><tr><td>Platinum Metallicum 30X HPUS</td><td>causeless crying, waking at night</td></tr><tr><td>Pulsatilla 6X HPUS</td><td>cries easily, inconsolable</td></tr><tr><td>Sulphur 12X HPUS</td><td>crying, restlessness, irritability</td></tr></tbody></table>"],"ask_doctor":["Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever."],"dosage_and_administration":["Directions ■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved."],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Children under 6 months</td><td>Ask a doctor before use.</td></tr><tr><td>Children 6 months   to under 1 year </td><td>At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.</td></tr><tr><td>Children 1 year   to under 3 years </td><td>At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.</td></tr></tbody></table>"],"effective_time":"20211220","id":"d39e88d5-38bc-2f7a-e053-2995a90a9eb2","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose."],"indications_and_usage":["Uses ■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Hyland's Naturals™ •baby• Calming Tablets* NO ARTIFICIAL FLAVORS, DYES or PARABENS Sleeplessness Fussiness Irritability 6+ MONTHS 125 QUICK-DISSOLVING TABLETS HOMEOPATHIC carton"],"purpose":["Active ingredients Purpose \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness, fussiness, and agitation Coffea Cruda 6X HPUS irritability Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated) restless sleep Lycopodium 30X HPUS unpredictable, irregular sleep Natrum Muriaticum 6X HPUS crying, irritability Platinum Metallicum 30X HPUS causeless crying, waking at night Pulsatilla 6X HPUS cries easily, inconsolable Sulphur 12X HPUS crying, restlessness, irritability"],"purpose_table":["<table width=\"85%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"2\"><content styleCode=\"italics\">&quot;HPUS&quot; indicates that the active ingredients are in the official Homeopathic Pharmacop&#x153;ia of the United States.</content></td></tr></tfoot><tbody><tr><td>Chamomilla 6X HPUS</td><td>occasional sleeplessness, fussiness, and agitation</td></tr><tr><td>Coffea Cruda 6X HPUS</td><td>irritability</td></tr><tr><td>Ignatia Amara 30X HPUS  (less than 0.0000000000001% Alkaloids, calculated) </td><td>restless sleep</td></tr><tr><td>Lycopodium 30X HPUS</td><td>unpredictable, irregular sleep</td></tr><tr><td>Natrum Muriaticum 6X HPUS</td><td>crying, irritability</td></tr><tr><td>Platinum Metallicum 30X HPUS</td><td>causeless crying, waking at night</td></tr><tr><td>Pulsatilla 6X HPUS</td><td>cries easily, inconsolable</td></tr><tr><td>Sulphur 12X HPUS</td><td>crying, restlessness, irritability</td></tr></tbody></table>"],"questions":["Questions or comments? www.hylands.com or (800) 624-9659"],"recent_major_changes":["Indications and Usage ■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior","Dosage and Administration (Directions) ■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved."],"recent_major_changes_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Children under 6 months</td><td>Ask a doctor before use.</td></tr><tr><td>Children 6 months   to under 1 year </td><td>At onset of symptoms, dissolve 2 tablets on tongue   every hour up to 4 hours. If symptoms persist,   2 tablets every 4 hours until relieved. </td></tr><tr><td>Children 1 year   to under 3 years </td><td>At onset of symptoms, dissolve 3 tablets on tongue   every hour up to 4 hours. If symptoms persist,   3 tablets every 4 hours until relieved. </td></tr></tbody></table>"],"set_id":"8f20251b-111b-4b7b-8098-4371d04004bd","spl_product_data_elements":["BABY CALMING matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur ACACIA LACTOSE, UNSPECIFIED FORM MATRICARIA RECUTITA MATRICARIA RECUTITA ARABICA COFFEE BEAN ARABICA COFFEE BEAN STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SODIUM CHLORIDE SODIUM CATION PLATINUM PLATINUM ANEMONE PULSATILLA ANEMONE PULSATILLA SULFUR SULFUR"],"spl_unclassified_section":["Drug Facts Drug Facts Active ingredients Purpose \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness, fussiness, and agitation Coffea Cruda 6X HPUS irritability Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated) restless sleep Lycopodium 30X HPUS unpredictable, irregular sleep Natrum Muriaticum 6X HPUS crying, irritability Platinum Metallicum 30X HPUS causeless crying, waking at night Pulsatilla 6X HPUS cries easily, inconsolable Sulphur 12X HPUS crying, restlessness, irritability","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["<table width=\"85%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"2\"><content styleCode=\"italics\">&quot;HPUS&quot; indicates that the active ingredients are in the official Homeopathic Pharmacop&#x153;ia of the United States.</content></td></tr></tfoot><tbody><tr><td>Chamomilla 6X HPUS</td><td>occasional sleeplessness, fussiness, and agitation</td></tr><tr><td>Coffea Cruda 6X HPUS</td><td>irritability</td></tr><tr><td>Ignatia Amara 30X HPUS  (less than 0.0000000000001% Alkaloids, calculated) </td><td>restless sleep</td></tr><tr><td>Lycopodium 30X HPUS</td><td>unpredictable, irregular sleep</td></tr><tr><td>Natrum Muriaticum 6X HPUS</td><td>crying, irritability</td></tr><tr><td>Platinum Metallicum 30X HPUS</td><td>causeless crying, waking at night</td></tr><tr><td>Pulsatilla 6X HPUS</td><td>cries easily, inconsolable</td></tr><tr><td>Sulphur 12X HPUS</td><td>crying, restlessness, irritability</td></tr></tbody></table>"],"version":"5","warnings":["Warnings Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever. Keep out of reach of children."]}