{"active_ingredient":["Active ingredient (in each 30 mL dose cup) Purpose Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid"],"ask_doctor":["Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • 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"],"dosage_and_administration":["Directions • take only one dose (30 mL) per day (24 hours) • only use dose cup provided Age Dose adults and children 12 years and over 30 mL at bedtime if needed or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">Dose</content></td></tr><tr><td>adults and children   12 years and over </td><td>30 mL at bedtime if needed   or as directed by a doctor </td></tr><tr><td>children under 12 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250311","id":"30131010-be71-c940-e063-6394a90a190a","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose."],"indications_and_usage":["Uses • for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of the reach of children . In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["M010"],"brand_name":["REVASOL SLEEP AID"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Rnv LLC"],"package_ndc":["84379-284-04"],"product_ndc":["84379-284"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1248354"],"spl_id":["30131010-be71-c940-e063-6394a90a190a"],"spl_set_id":["30131010-be70-c940-e063-6394a90a190a"],"substance_name":["DIPHENHYDRAMINE HCL"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other information • each 30 mL dose cup contains: sodium 4 mg • store between 15-30°C (59-86°F). • TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing."],"package_label_principal_display_panel":["REVASOL SLEEP.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Nightime sleep-aid"],"questions":["Questions or comments 1-888-446-4753 Monday - Friday (9 AM - 5 PM EST)"],"set_id":"30131010-be70-c940-e063-6394a90a190a","spl_product_data_elements":["REVASOL SLEEP AID Diphenhydramine HCl SUCRALOSE SORBITOL SOLUTION 70% WATER PROPYLENE GLYCOL DIPHENHYDRAMINE HCL DIPHENHYDRAMINE SODIUM BENZOATE FD&C RED NO. 40 SODIUM CITRATE CITRIC ACID FD&C BLUE NO. 1 GLYCERIN MENTHOL"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical ilness."],"version":"1","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"],"when_using":["When using this product • avoid alcoholic beverages"]}