{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen, USP 500 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have ■ liver disease ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers"],"do_not_use":["Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over - take 2 caplets at bedtime - do not take more than 2 caplets of this product in 24 hours children under 12 years - do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage."],"effective_time":"20170207","id":"47f839b9-ac8b-161c-e054-00144ff8d46c","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, polysorbate 80, polyethylene glycol 400, povidone, stearic acid, titanium dioxide"],"indications_and_usage":["Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"openfda":{"application_number":["part343"],"brand_name":["Acetaminophen Diphenhydramine HCl"],"generic_name":["ACETAMINOPHEN DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Consortium,LLC"],"nui":["N0000000190","N0000175587"],"package_ndc":["68016-654-05","68016-654-10"],"pharm_class_epc":["Histamine-1 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H1 Receptor Antagonists [MoA]"],"product_ndc":["68016-654"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["47f839b9-ac8b-161c-e054-00144ff8d46c"],"spl_set_id":["47f839b9-ac8a-161c-e054-00144ff8d46c"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE"],"unii":["362O9ITL9D","8GTS82S83M"],"upc":["0840986031847","0840986031830"]},"other_safety_information":["Other information ■ store between 20°-25°C (68°-77°F) ■ do not use if carton is opened, or neck wrap or foil inner seal broken or mising ■ see end panel for lot number and expiration date"],"overdosage":["Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms"],"package_label_principal_display_panel":["50 count","100 count"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep aid"],"questions":["Questions and comments? call 1-844-724-7347 Mon-Fri 9:00 AM to 4:30 PM EST"],"set_id":"47f839b9-ac8a-161c-e054-00144ff8d46c","spl_product_data_elements":["Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE DIPHENHYDRAMINE STARCH, PREGELATINIZED CORN CELLULOSE, MICROCRYSTALLINE POVIDONE G651"],"stop_use":["Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur These could be signs of a serious condition."],"version":"1","warnings":["Warnings","Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product"],"when_using":["When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery"]}