{"active_ingredient":["Active ingredient (in each capsule) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the 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: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve"],"effective_time":"20231226","id":"0d63c644-46c2-b4c0-e063-6394a90a9dd3","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide"],"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. In case of overdose, get medical help or contact a Poison Control Centre right away."],"openfda":{"application_number":["M010"],"brand_name":["nighttime sleep-aid"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Bionpharma Inc."],"package_ndc":["69452-322-79"],"product_ndc":["69452-322"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["0d63c644-46c2-b4c0-e063-6394a90a9dd3"],"spl_set_id":["c0074c77-287e-6c26-e053-2995a90a4d31"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["160's count Label † Compare to the active ingredient in Unisom ® SleepGels ® NDC 69452-322-79 a+health maximum strength nighttime sleep-aid diphenhydramine HCl capsules, 50 mg • fall asleep fast • sleep soundly • safe, non-habit forming 160 softgels** **liquid-filled capsules one softgel per dose front back"],"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 toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)"],"set_id":"c0074c77-287e-6c26-e053-2995a90a4d31","spl_product_data_elements":["nighttime sleep-aid Diphenhydramine HCl GLYCERIN GELATIN LECITHIN, SOYBEAN WATER SORBITAN MEDIUM-CHAIN TRIGLYCERIDES TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE P50"],"spl_unclassified_section":["DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION ” IS BROKEN OR MISSING. † This product is not manufactured or distributed by the owners of Unisom ® SleepGels ® . Made in USA using domestic and imported materials. Manufactured for: Bionpharma Inc. Princeton, NJ 08540 R0223 Lot No.: Exp. Date L0000704"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other information ■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light"],"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. Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema 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 or tranquilizers. When using this product ■ avoid alcoholic beverages ■ 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, consult your doctor. Insomnia may be a symptom of 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 Centre right away."],"when_using":["When using this product ■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery"]}