{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"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 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":"20260511","id":"2e788cf8-a210-40b1-9644-b2cdbda6c6b6","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 Nighttime"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["CVS Pharmacy"],"package_ndc":["69842-916-32","69842-916-96","69842-916-64","69842-916-02"],"product_ndc":["69842-916"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["2e788cf8-a210-40b1-9644-b2cdbda6c6b6"],"spl_set_id":["0be4ef9a-2484-41dd-8bb8-e92d411f1384"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other information store between 15-30ºC (59-86ºF)"],"package_label_principal_display_panel":["Principal Display Panel Compare to Unisom® SleepGels® active ingredient* Maximum Strength† SLEEP-AID Diphenhydramine HCl, 50 mg Nighttime Sleep-Aid Fall Asleep Fast SOFTGELS (ONE SOFTGEL PER DOSE) †Under OTC monograph. *This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895","Product Label CVS 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 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"0be4ef9a-2484-41dd-8bb8-e92d411f1384","spl_product_data_elements":["Sleep Aid Nighttime Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED LECITHIN, SOYBEAN WATER SORBITOL SORBITAN 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."],"version":"10","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."]}