{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions • take only one dose per day (24 hours) • adults and children 12 years and over: take 2 softgels at bedtime if needed or as directed by a doctor • children under 12 years: do not use"],"effective_time":"20250101","id":"abe76ad8-3da3-48f9-9704-d230e846a5e1","inactive_ingredient":["Inactive ingredients FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink"],"indications_and_usage":["Uses • for 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Sleep-Aid Softgel"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY, INC"],"package_ndc":["51316-779-24","51316-779-48"],"product_ndc":["51316-779"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["abe76ad8-3da3-48f9-9704-d230e846a5e1"],"spl_set_id":["8b0fa259-6702-4667-bac6-f7d0b0839ae0"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging Sleepaid-1"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 9am-4:30pm EST"],"set_id":"8b0fa259-6702-4667-bac6-f7d0b0839ae0","spl_product_data_elements":["Nighttime Sleep-Aid Softgel Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED WATER SORBITOL SORBITAN 779"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredient in Vicks ® ZzzQuil™ NIGHTTIME SLEEP-AID LiquidCaps™** Non-habit forming Not for treating pain, cold or flu **This product is not manufactured or distributed by The Proctor & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps™. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Product of UAE Packaged and Quality Assured in the USA Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2021 CVS/pharmacy CVS.com ® 1-800-SHOP CVS"],"storage_and_handling":["Other information • store at 20-25°C (68-77°F)"],"version":"4","warnings":["Warnings Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}