{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"dosage_and_administration":["Directions adults and children 12 years and over take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">adults and children 12 years and over</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">children under 12 years</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> do not use</td></tr></tbody></table>"],"effective_time":"20250319","id":"9f2a9500-3de5-4994-9143-dbebf2f4b257","inactive_ingredient":["Inactive ingredients edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide"],"indications_and_usage":["Uses for relief of occasional sleeplessness reduces time to fall alseep 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":["RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc."],"package_ndc":["70692-834-71"],"product_ndc":["70692-834"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["9f2a9500-3de5-4994-9143-dbebf2f4b257"],"spl_set_id":["2d64f5c2-dfa9-e5f5-e063-6294a90a0711"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0370692000641"]},"package_label_principal_display_panel":["Packaging Nighttime834-2"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST"],"set_id":"2d64f5c2-dfa9-e5f5-e063-6294a90a0711","spl_product_data_elements":["RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE 903"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredient of Unisom ® SleepGels ® * fall asleep fast safe, non-habit forming TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Chatem, Inc., owner of the registered trademark Unisom ® . Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA"],"storage_and_handling":["Other information store at room temperature between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) protect from light, heat and moisture"],"version":"2","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 disease a breathing problem such as emphysema, asthma, or chronic bronchitis difficulty in urination due to an enlargement of 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."]}