{"active_ingredient":["Drug Facts Active ingredients (in each caplet) Acetaminophen USP 500 mg Diphenhydramine HCl USP 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"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"636.804\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 12 years and over  </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Disc\"><item>take 2 caplets at bedtime</item><item>do not take more than 2 caplets of this product in 24 hours</item></list></td></tr><tr><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\">children under 12 years  </td><td align=\"justify\" styleCode=\"Rrule\" valign=\"top\">do not use  </td></tr></tbody></table>"],"effective_time":"20231116","id":"0a424974-5d8a-02d5-e063-6394a90a94ec","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, corn starch, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80, potassium sorbate, povidone, propylene glycol, purified water, sodium starch glycolate, titanium dioxide, triacetin"],"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 reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets AUROHEALTH NDC 58602-743-21 *Compare to the active ingredient in TYLENOL ® PM Extra Strength Extra Strength Pain Reliever, Nighttime Sleep Aid AUROPHEN PM Acetaminophen and Diphenhydramine HCl Caplets 500 mg/25 mg Non-habit forming 100 Caplets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep aid"],"questions":["Questions or comments? 1-855-274-4122 Distributed by: Aurohealth LLC. 2572 Brunswick Pike Lawrenceville, NJ 08648"],"set_id":"994351af-0c08-436f-a623-149ff7c7c463","spl_product_data_elements":["Aurophen PM Extra Strength Acetaminophen and Diphenhydramine HCl SILICON DIOXIDE STARCH, CORN FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 POTASSIUM SORBATE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Light Blue Biconvex N35"],"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."],"storage_and_handling":["Other information each caplet contains: sodium 1.36 mg store between 20-25°C (68-77°F) do not use if carton is opened, or seal under cap is torn or missing."],"version":"4","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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away."],"when_using":["When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"]}