{"active_ingredient":["Active ingredients (in each gelcap) Acetaminophen 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 difficulty in urination due to enlargement of the 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"],"dosage_and_administration":["Directions do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use"],"effective_time":"20260306","id":"47ca6770-e94f-4ccf-ac53-ddbccfd93d22","inactive_ingredient":["Inactive ingredients ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["Acetaminophen PM Extra Strength"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY"],"package_ndc":["69842-956-31","69842-956-09","69842-956-13"],"product_ndc":["69842-956"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["47ca6770-e94f-4ccf-ac53-ddbccfd93d22"],"spl_set_id":["67a190c3-7de0-4f57-be94-d6b8285e1220"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["Principal display panel CVS ™ actual size Extra Strength ACETAMINOPHEN PM Acetaminophen , 500 mg Diphenhydramine HCl, 25 mg Pain Reliever, Nighttime Sleep-Aid Compare to Tylenol® PM Extra Strength active ingredients* 80 GELCAPS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 50844 ORG032455631 CVS 44-556 CVS 44-556"],"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? 1-800-426-9391"],"set_id":"67a190c3-7de0-4f57-be94-d6b8285e1220","spl_product_data_elements":["Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AMMONIA SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 3 GELATIN, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SHELLAC STEARIC ACID TITANIUM DIOXIDE light Dark L;6"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. any new symptoms appear redness or swelling is present fever gets worse or lasts more than 3 days"],"storage_and_handling":["Other information avoid high humidity store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package"],"version":"12","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 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. 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 Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. any new symptoms appear redness or swelling is present fever gets worse or lasts more than 3 days 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery"]}