{"active_ingredient":["Diphenhydramine HCl 25mg"],"dosage_and_administration":["do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor children under 12 years of age: do not use"],"effective_time":"20240101","id":"8afba990-140d-4ab7-985a-f8ce27d8b661","inactive_ingredient":["polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water."],"indications_and_usage":["helps fall asleep faster for relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"other_safety_information":["store at room temperature between 20-25°C (68-77ºF). avoid excessive heat, cold and humidity. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."],"overdosage":["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."],"package_label_principal_display_panel":["784"],"purpose":["Sleep-aid"],"set_id":"96a07573-f3bd-528c-e053-2995a90a81c5","spl_product_data_elements":["Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride WATER FD&C BLUE NO. 1 SORBITAN POLYETHYLENE GLYCOL 400 SORBITOL PROPYLENE GLYCOL GLYCERIN GELATIN, UNSPECIFIED POVIDONE K30 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C RED NO. 40 784 Oblong"],"version":"6","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 night-time cold/flu products Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as asthma, emphysema or chronic bronchitis heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid When using this product drowsiness may occur avoid alcoholic drinks and other drugs that cause drowsiness Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use."]}