{"active_ingredient":["Active ingredient (in each tablet) Doxylamine succinate 25 mg"],"ask_doctor":["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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs"],"do_not_use":["Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep"],"dosage_and_administration":["Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use"],"effective_time":"20260327","id":"b218dc14-c46a-4fef-a17e-ffb3edd284f7","inactive_ingredient":["Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"indications_and_usage":["Use helps to reduce difficulty in 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 Center right away."],"openfda":{"application_number":["ANDA040564"],"brand_name":["Nighttime Sleep Aid"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["L.N.K. International, Inc."],"package_ndc":["50844-386-19","50844-386-90","50844-386-27","50844-386-22","50844-386-96"],"product_ndc":["50844-386"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["b218dc14-c46a-4fef-a17e-ffb3edd284f7"],"spl_set_id":["918ad808-ccfd-429f-9052-19905a634606"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"],"upc":["0350844386199"]},"package_label_principal_display_panel":["Principal display panel QUALITY +PLUS NDC 50844-386-19 *Compare to active ingredient in Unisom® SleepTabs® NIGHTTIME SLEEP AID Doxylamine succinate tablets, 25 mg Nighttime Sleep-Aid One Tablet Per Dose 8 Tablets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV0123B38619 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 44-386 Quality Plus 44-386"],"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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday"],"set_id":"918ad808-ccfd-429f-9052-19905a634606","spl_product_data_elements":["Nighttime Sleep Aid Doxylamine succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;386"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number"],"version":"10","warnings":["Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep 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 any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. 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 Center right away."],"when_using":["When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime"]}