{"active_ingredient":["Active Ingredient and Purpose . Active ingredient (in each 10 mL vial) 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 (in each 10 mL vial)</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 have trouble urinating due to an enlarged prostate gland are taking sedatives or tranquilizers"],"do_not_use":["Do not use with any other product containing diphenhydramine, even one used on skin on children under 12 years of age"],"dosage_and_administration":["Directions do not take more than directed follow the “Easy to Use” instructions on pouch Age Dose Adults and children 12 years and older take 2 vials at bedtime, if needed children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">Dose</content></td></tr><tr><td>Adults and children 12 years and older</td><td>take 2 vials at bedtime, if needed</td></tr><tr><td>children under 12 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260331","id":"4e58cc8b-5c0c-8da6-e063-6394a90a13a0","inactive_ingredient":["Inactive ingredients Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol"],"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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["M010"],"brand_name":["Calmco Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["CalmCo LLC"],"package_ndc":["73282-2525-1","73282-2525-2"],"product_ndc":["73282-2525"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["4e58cc8b-5c0c-8da6-e063-6394a90a13a0"],"spl_set_id":["471d4c70-813a-19de-e063-6394a90aeb25"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other information each 10 mL vial contains: sodium 4 mg store between 68-77°F (20-25°C) do not use if pouch has been torn open or vial is punctured or open"],"package_label_principal_display_panel":["Principal Display Panel SLEEP AID PDP"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a healthcare professional before use"],"purpose":["Active ingredient (in each 10 mL vial) 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 (in each 10 mL vial)</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? +1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com Distributed by: CalmCo LLC , Sarasota, FL 34240 Made in Dominican Republic"],"set_id":"471d4c70-813a-19de-e063-6394a90aeb25","spl_product_data_elements":["Calmco Sleep Aid Diphenhydramine HCl SUCRALOSE ANHYDROUS CITRIC ACID SORBITOL SODIUM BENZOATE GLYCERIN WATER PROPYLENE GLYCOL XYLITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARBOXYMETHYLCELLULOSE"],"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 with any other product containing diphenhydramine, even one used on skin on children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma have trouble urinating due to an enlarged prostate gland are taking sedatives or tranquilizers When using this product avoid consuming alcohol beverages 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 breastfeeding, ask a healthcare professional before use KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["When using this product avoid consuming alcohol beverages"]}