{"active_ingredient":["DRUG FACTS Active ingredient (in each soft gel) Diphenhydramine HCL 50 mg"],"dosage_and_administration":["Directions adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20250109","id":"2b4a3632-89cf-8d7d-e063-6294a90a71e1","inactive_ingredient":["Inactive Ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink"],"indications_and_usage":["USES Use for relief of occasional sleeplessness."],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M010"],"brand_name":["SleepAid (Diphenhydramine HCL)"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["APNAR PHARMA LP"],"package_ndc":["24689-154-01"],"product_ndc":["24689-154"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["2b4a3632-89cf-8d7d-e063-6294a90a71e1"],"spl_set_id":["faaf5d51-d81d-3acc-e053-6294a90ae08f"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0324689154015"]},"package_label_principal_display_panel":["NDC 24689-154-01 SleepAid Diphenhydramine HCL 50 mg Safe, non habit-forming One softgel per dose Made in USA 100 Soft gels SleepAid-Diphenhydramine HCL Capsule-50 mg-label"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? Call 1-855-642-2594"],"set_id":"faaf5d51-d81d-3acc-e053-6294a90ae08f","spl_product_data_elements":["SleepAid (Diphenhydramine HCL) Diphenhydramine HCL FD&C BLUE NO. 1 GLYCERIN SORBITOL GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITAN WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AD1"],"spl_unclassified_section":["*Compare to active ingredient in Unisom ® SleepGels ® *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520"],"storage_and_handling":["Other information store at room temperature 15º to 30º C (59º to 86º F) avoid excessive heat do not use if imprinted safety seal under cap is broken or missing"],"version":"2","warnings":["Warnings Do not use for children under 12 years of age with any other products 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."]}