{"active_ingredient":["Active ingredients Purpose Aconitum Napellus 6X HPUS physical & mental restlessness Calcarea Phosphorica 12X HPUS peevishness Chamomilla 6X HPUS irritability, restlessness, occasional sleeplessness Cina 6X HPUS irritability of temper Lycopodium 6X HPUS lack of focus, extreme sensitivity Natrum Muriaticum 6X HPUS irritability, crying, oversensitivity Pulsatilla 6X HPUS occasional sleeplessness from travel Sulphur 6X HPUS irritability, peevishness \"HPUS\" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States."],"active_ingredient_table":["
Active ingredientsPurpose
Aconitum Napellus 6X HPUSphysical & mental restlessness
Calcarea Phosphorica 12X HPUSpeevishness
Chamomilla 6X HPUSirritability, restlessness, occasional sleeplessness
Cina 6X HPUSirritability of temper
Lycopodium 6X HPUSlack of focus, extreme sensitivity
Natrum Muriaticum 6X HPUSirritability, crying, oversensitivity
Pulsatilla 6X HPUSoccasional sleeplessness from travel
Sulphur 6X HPUSirritability, peevishness
"],"ask_doctor":["Consult a physician if Symptoms persist for more than 7 days or worsen."],"do_not_use":["Do not use More than directed."],"dosage_and_administration":["Directions Children 2 years to under 6 years Dissolve 2 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved. Children 6 years to under 12 years Dissolve 3 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved. Adults and children 12 years and over Dissolve 4 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved."],"dosage_and_administration_table":["
Children 2 years to under 6 years Dissolve 2 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved.
Children 6 years to under 12 years Dissolve 3 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved.
Adults and children 12 years and over Dissolve 4 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved.
"],"effective_time":"20230315","id":"f6f7ab8c-ffa7-6299-e053-6394a90ab0d8","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose"],"indications_and_usage":["Uses ■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ physical or mental restlessness ■ peevishness ■ crying oversensitivity ■ lack of focus"],"keep_out_of_reach_of_children":["Keep this and all medications out of the reach of children."],"openfda":{},"other_safety_information":["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.","Other Information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing. ■ The inner packaged bottle is child-resistant."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL HOMEOPATHIC NDC 54973-3161-1 2-12 YEARS NEW LOOK 4 KIDS SINCE 1903 Hyland's Calm & Restful* Relieves irritability, restlessness and occasional sleeplessness NATURAL RELIEF NO ARTIFICIAL FLAVORS, NO DYES or PARABENS 125 QUICK-DISSOLVING TABLETS *SEE NOTE ON SIDE PANEL BELOW DRUG FACTS carton"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding As with any drug, ask a doctor before use if pregnant or breast-feeding."],"purpose":["Temporarily relieves symptoms of irritability or restlessness in children, including: occasional sleeplessness, physical or mental restlessness, peevishness, crying, oversensitivity, lack of focus"],"questions":["Questions or comments? (800) 624-9659"],"recent_major_changes":["Indications and Usage Uses ■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ physical or mental restlessness ■ peevishness ■ crying ■ oversensitivity ■ lack of focus","Dosage and Administration Directions Children 2 years to under 6 years Dissolve 2 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved. Children 6 years to under 12 years Dissolve 3 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved. Adults and children 12 years and over Dissolve 4 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved."],"recent_major_changes_table":["
Children 2 yearsto under 6 yearsDissolve 2 tablets under tongue every 15 minutesup to 8 doses, then every 4 hours until relieved.
Children 6 yearsto under 12 yearsDissolve 3 tablets under tongue every 15 minutesup to 8 doses, then every 4 hours until relieved.
Adults and children12 years and overDissolve 4 tablets under tongue every 15 minutesup to 8 doses, then every 4 hours until relieved.
"],"set_id":"8dae1ad1-14fa-4e4e-8c76-889ff1d0bee1","spl_product_data_elements":["CALM N RESTFUL 4 KIDS aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur ACACIA LACTOSE ACONITUM NAPELLUS ROOT ACONITUM NAPELLUS ROOT CALCIUM PHOSPHATE CALCIUM CATION CHAMOMILE CHAMOMILE ARTEMISIA CINA PRE-FLOWERING TOP ARTEMISIA CINA PRE-FLOWERING TOP LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SODIUM CHLORIDE CHLORIDE ION PULSATILLA VULGARIS PULSATILLA VULGARIS SULFUR SULFUR"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose Aconitum Napellus 6X HPUS physical & mental restlessness Calcarea Phosphorica 12X HPUS peevishness Chamomilla 6X HPUS irritability, restlessness, occasional sleeplessness Cina 6X HPUS irritability of temper Lycopodium 6X HPUS lack of focus, extreme sensitivity Natrum Muriaticum 6X HPUS irritability, crying, oversensitivity Pulsatilla 6X HPUS occasional sleeplessness from travel Sulphur 6X HPUS irritability, peevishness \"HPUS\" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.","Drug Facts (continued) Other Information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing. ■ The inner packaged bottle is child-resistant. Inactive ingredients Acacia Gum, Lactose Questions or comments? (800) 624-9659","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["
Active ingredientsPurpose
Aconitum Napellus 6X HPUSphysical & mental restlessness
Calcarea Phosphorica 12X HPUSpeevishness
Chamomilla 6X HPUSirritability, restlessness, occasional sleeplessness
Cina 6X HPUSirritability of temper
Lycopodium 6X HPUSlack of focus, extreme sensitivity
Natrum Muriaticum 6X HPUSirritability, crying, oversensitivity
Pulsatilla 6X HPUSoccasional sleeplessness from travel
Sulphur 6X HPUSirritability, peevishness
"],"version":"8","warnings":["Warnings If pregnant or breastfeeding As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use More than directed. 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."]}