{"active_ingredient":["Active ingredient and Purpose Active ingredient Purpose Diphenhydramine HCl 25 mg .................. Nighttime sleep aid"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Diphenhydramine HCl 25 mg ..................</td><td>Nighttime sleep aid</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions take only 1 dose per day (24 hours) chew each piece thoroughly before swallowing Age (Yrs) Dose (per piece) adults and children 12 years and over 1 to 2 pieces (25 mg to 50 mg) children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age (Yrs)</content></td><td><content styleCode=\"bold\">Dose (per piece)</content></td></tr><tr><td><paragraph>adults and children 12 years and over</paragraph></td><td>1 to 2 pieces (25 mg to 50 mg)</td></tr><tr><td>children under 12 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20241207","id":"28b60a20-e53c-8ebe-e063-6394a90af031","inactive_ingredient":["Inactive Ingredients FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate."],"indications_and_usage":["Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M010"],"brand_name":["CalmCo Sleep Aid Gummy Bite"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["CalmCo LLC"],"package_ndc":["73282-2518-1"],"product_ndc":["73282-2518"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["28b60a20-e53c-8ebe-e063-6394a90af031"],"spl_set_id":["0c534cbd-40e6-8af0-e063-6394a90a5605"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other Information each piece: contains : sodium 9 mg . low sodium Store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing."],"package_label_principal_display_panel":["Principal Display Panel Sleep Aid PDP sleep aid peel back"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Active ingredient Purpose Diphenhydramine HCl 25 mg .................. Nighttime sleep aid"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Diphenhydramine HCl 25 mg ..................</td><td>Nighttime sleep aid</td></tr></tbody></table>"],"questions":["Questions or Comments? Call 941-203-4590 or visit www.calmco.com"],"set_id":"0c534cbd-40e6-8af0-e063-6394a90a5605","spl_product_data_elements":["CalmCo Sleep Aid Gummy Bite Diphenhydramine HCl CARRAGEENAN STARCH, CORN MALTITOL GLYCERYL MONO AND DIPALMITOSTEARATE NEOTAME SODIUM CHLORIDE POVIDONE K30 SUCRALOSE POLYETHYLENE GLYCOL 400 TRISODIUM CITRATE DIHYDRATE PROPYLENE GLYCOL SUCROSE CORN SYRUP HYDROXYPROPYL BETADEX ACACIA WATER FD&C RED NO. 40 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness"],"version":"2","warnings":["Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product avoid alcoholic drinks"]}