{"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":"20250523","id":"bdc4ec0b-1b9d-4a6d-b736-eef61a2550b3","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":["Nighttime Sleep Aid Maximum Strength"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Care One (Retail Business Services, LLC.)"],"package_ndc":["72476-916-32"],"product_ndc":["72476-916"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["bdc4ec0b-1b9d-4a6d-b736-eef61a2550b3"],"spl_set_id":["536cd7d6-a470-4614-89c8-6c3ada582a90"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0341520318856"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the Active Ingredient in Unisom® SleepGels®† Maximum Strength NIGHTTIME SLEEP - AID Diphenhydramine HCI 50 mg Helps to Reduce Difficulty Falling Asleep SOFTGELS** **Liquid Filled Capsules TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. **This product is not manufactured or distributed by Sanofi Consumer Healthcare NA., distributor of Unisom® SleepGels®. DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back.","Package Label CARE ONEMaximum Strength Nighttime 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"],"set_id":"536cd7d6-a470-4614-89c8-6c3ada582a90","spl_product_data_elements":["Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LECITHIN, SOYBEAN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL 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 15-30°C (59°-86°F)"],"version":"5","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."]}