{"active_ingredient":["Active ingredients Purpose \"HPUS\" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion"],"active_ingredient_table":["
Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUSstress, nervousness
Calcarea Phosphorica 3X HPUSrestlessness
Chamomilla 4X HPUSnervous irritability
Ferrum Phosphoricum 3X HPUSnervousness
Humulus Lupulus 4X HPUSoccasional sleeplessness
Kali Phosphoricum 3X HPUSirritability
Magnesia Phosphorica 3X HPUSmental anxiousness
Natrum Phosphoricum 3X HPUSanxiousness
Passiflora 4X HPUSrestless sleep from exhaustion
"],"dosage_and_administration":["Directions ■ Use as directed. Adults and children 12 years and over As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. Children 6 years to under 12 years As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime."],"dosage_and_administration_table":["
Adults and children 12 years and over As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime.
Children 6 years to under 12 years As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime.
"],"effective_time":"20260813","id":"58f195ef-ccf8-4142-e063-6394a90aa962","inactive_ingredient":["Inactive ingredients Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca)."],"indications_and_usage":["Uses ■ Temporarily relieves symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"brand_name":["CALMS FORTE"],"generic_name":["AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER"],"is_original_packager":[true],"manufacturer_name":["Hyland's Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0008672"],"package_ndc":["54973-3257-1","54973-3257-2","54973-3257-3","54973-3257-7"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Food Additives [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":["54973-3257"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["58f195ef-ccf8-4142-e063-6394a90aa962"],"spl_set_id":["63ce9942-a299-4d9b-b63b-35b297472dc9"],"substance_name":["AVENA SATIVA FLOWERING TOP","TRIBASIC CALCIUM PHOSPHATE","MATRICARIA RECUTITA","FERROSOFERRIC PHOSPHATE","HOPS","POTASSIUM PHOSPHATE, DIBASIC","MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE","SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","PASSIFLORA INCARNATA FLOWER"],"unii":["MA9CQJ3F7F","91D9GV0Z28","G0R4UBI2ZZ","91GQH8I5F7","01G73H6H83","CI71S98N1Z","HF539G9L3Q","70WT22SF4B","K8F3G29S6Z"]},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON CAFO00000T50LBLH2 CAFO00000T50LBLH2","PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON HNCF0000T100LBLH2 HNCF0000T100LBLH2"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding Ask a health professional before use."],"purpose":["Active ingredients Purpose \"HPUS\" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion"],"purpose_table":["
Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUSstress, nervousness
Calcarea Phosphorica 3X HPUSrestlessness
Chamomilla 4X HPUSnervous irritability
Ferrum Phosphoricum 3X HPUSnervousness
Humulus Lupulus 4X HPUSoccasional sleeplessness
Kali Phosphoricum 3X HPUSirritability
Magnesia Phosphorica 3X HPUSmental anxiousness
Natrum Phosphoricum 3X HPUSanxiousness
Passiflora 4X HPUSrestless sleep from exhaustion
"],"questions":["Questions? www.hylands.com or (800) 624-9659"],"recent_major_changes":["Uses occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness and irritability. Changed \"and\" to \"or\"","Dosage and Administration Adults and children 12 years and over As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. Children 6 years to under 12 years As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime."],"recent_major_changes_table":["
Adults and children12 years and overAs a relaxant: swallow 1-2 tablets with water until relieved, up to 3 timesper day. For occasional sleeplessness: 1-3 tablets before bedtime.
Children 6 yearsto under 12 yearsAs a relaxant: swallow 1 tablet with water until relieved, up to 3 timesper day. For occasional sleeplessness: 1-2 tablets before bedtime.
"],"set_id":"63ce9942-a299-4d9b-b63b-35b297472dc9","spl_product_data_elements":["CALMS FORTE avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP TRIBASIC CALCIUM PHOSPHATE PHOSPHATE ION MATRICARIA RECUTITA MATRICARIA RECUTITA FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE HOPS HOPS POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION PASSIFLORA INCARNATA FLOWER PASSIFLORA INCARNATA FLOWER LACTOSE, UNSPECIFIED FORM MAGNESIUM PALMITOSTEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN STARCH, TAPIOCA HYL;CF"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose \"HPUS\" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["
Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUSstress, nervousness
Calcarea Phosphorica 3X HPUSrestlessness
Chamomilla 4X HPUSnervous irritability
Ferrum Phosphoricum 3X HPUSnervousness
Humulus Lupulus 4X HPUSoccasional sleeplessness
Kali Phosphoricum 3X HPUSirritability
Magnesia Phosphorica 3X HPUSmental anxiousness
Natrum Phosphoricum 3X HPUSanxiousness
Passiflora 4X HPUSrestless sleep from exhaustion
"],"stop_use":["Stop use and ask a doctor if Symptoms persist more than 7 days or worsen."],"version":"13","warnings":["Warnings Stop use and ask a doctor if Symptoms persist more than 7 days or worsen. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children"]}