{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if 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 in children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20240422","id":"492b4206-5f87-4f5a-80f2-2c33b01f720a","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink"],"indications_and_usage":["Use for relief of occasional sleeplessness."],"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":["Sleep Aid Maximum Strength"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["QUALITY CHOICE (Chain Drug Marketing Association)"],"package_ndc":["63868-415-32"],"product_ndc":["63868-415"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["492b4206-5f87-4f5a-80f2-2c33b01f720a"],"spl_set_id":["29b49616-ee5a-4574-81f1-0052addb8f66"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0635515996816"]},"package_label_principal_display_panel":["Principal Display Panel †Compare to the Active Ingredient in Unisom® SleepGels® Sleep-Aid Maximum Strength Nighttime Sleep-Aid Diphenhydramine HCl, 50 mg Help to Reduce Difficulty Falling Asleep Softgels †This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com","Product Label QUALITY CHOICE Maximum Strength Sleep-Aid Diphenhydramine HCL 50 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? Call 800-935-2362 Monday-Friday 9AM-5PM EST"],"set_id":"29b49616-ee5a-4574-81f1-0052addb8f66","spl_product_data_elements":["Sleep Aid Maximum Strength Diphenhydramine HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL PROPYLENE GLYCOL LECITHIN, SOYBEAN LIGHT MINERAL OIL MANNITOL PC5"],"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."],"storage_and_handling":["Other information store between 15-30ºC (59-86ºF)"],"version":"3","warnings":["Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if 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."]}