{"active_ingredient":["Active ingredients Active ingredients Purpose Calcarea Carbonica 3X HPUS sinus pressure, congestion, headache Hydrastis Canadensis 6X HPUS sinus headache Kali Bichromicum 6X HPUS nasal congestion, sinus pressure Pulsatilla Nigricans 6X HPUS sinus pressure, headache \"HPUS\" is the Homeopathic Pharmacopoeia of the United States."],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Calcarea Carbonica 3X HPUS</td><td>sinus pressure, congestion, headache</td></tr><tr><td>Hydrastis Canadensis 6X HPUS</td><td>sinus headache</td></tr><tr><td>Kali Bichromicum 6X HPUS</td><td>nasal congestion, sinus pressure</td></tr><tr><td>Pulsatilla Nigricans 6X HPUS</td><td>sinus pressure, headache</td></tr></tbody></table>"],"dosage_and_administration":["Directions ■ Use as directed. Children 2 years to under 6 years At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist, 1 tablet every 4 hours until relieved. Children 6 years to under 12 years At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Adults and children 12 years and over At onset of symptoms, dissolve 3 tablets under 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 2 years   to under 6 years </td><td>At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist,   1 tablet every 4 hours until relieved. </td></tr><tr><td>Children 6 years   to under 12 years </td><td>At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist,   2 tablets every 4 hours until relieved. </td></tr><tr><td>Adults and children   12 years and over </td><td>At onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours. If symptoms persist,   3 tablets every 4 hours until relieved. </td></tr></tbody></table>"],"effective_time":"20250626","id":"387c5392-b956-044f-e063-6394a90a9d86","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose."],"indications_and_usage":["Uses ■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: ■ nasal congestion ■ sinus pressure ■ headache"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"brand_name":["4 Kids Stuffy Nose and Sinus"],"generic_name":["PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL AND POTASSIUM DICHROMATE"],"is_original_packager":[true],"manufacturer_name":["Hylands Inc."],"package_ndc":["54973-3406-1","54973-3406-2"],"product_ndc":["54973-3406"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["387c5392-b956-044f-e063-6394a90a9d86"],"spl_set_id":["a00f1db3-cae4-5729-e053-2a95a90ab001"],"substance_name":["OYSTER SHELL CALCIUM CARBONATE, CRUDE","GOLDENSEAL","POTASSIUM DICHROMATE","PULSATILLA PRATENSIS WHOLE"],"unii":["2E32821G6I","ZW3Z11D0JV","T4423S18FM","8E272251DI"]},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["Principal Display Panel Hyland's •kids• STUFFY NOSE & SINUS* NO ARTIFICIAL FLAVORS, DYES or PARABENS Nasal Congestion Sinus Pressure Headache 2- 12 YEARS 50 QUICK-DISSOLVING TABLETS HOMEOPATHIC SSFK00000T50LBLH1"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding ask a health professional before use."],"purpose":["Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache"],"questions":["Questions? www.hylands.com or care@hylands.com"],"recent_major_changes":["Indications and Usage Uses Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion sinus pressure headache"],"set_id":"a00f1db3-cae4-5729-e053-2a95a90ab001","spl_product_data_elements":["4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE GOLDENSEAL GOLDENSEAL POTASSIUM DICHROMATE DICHROMATE ION ACACIA LACTOSE MONOHYDRATE ANHYDROUS LACTOSE PULSATILLA PRATENSIS WHOLE PULSATILLA PRATENSIS WHOLE"],"spl_unclassified_section":["Drug Facts Active ingredients Active ingredients Purpose Calcarea Carbonica 3X HPUS sinus pressure, congestion, headache Hydrastis Canadensis 6X HPUS sinus headache Kali Bichromicum 6X HPUS nasal congestion, sinus pressure Pulsatilla Nigricans 6X HPUS sinus pressure, headache \"HPUS\" is the Homeopathic Pharmacopoeia of the United States.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Calcarea Carbonica 3X HPUS</td><td>sinus pressure, congestion, headache</td></tr><tr><td>Hydrastis Canadensis 6X HPUS</td><td>sinus headache</td></tr><tr><td>Kali Bichromicum 6X HPUS</td><td>nasal congestion, sinus pressure</td></tr><tr><td>Pulsatilla Nigricans 6X HPUS</td><td>sinus pressure, headache</td></tr></tbody></table>"],"stop_use":["Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever."],"version":"6","warnings":["Warnings Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children."]}