{"active_ingredient":["Drug Facts Active ingredients (in each caplet) 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 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 product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 of age 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"],"effective_time":"20260226","id":"4bbe57b4-c0c6-c37f-e063-6294a90a7dd7","inactive_ingredient":["croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, 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."],"openfda":{"application_number":["M013"],"brand_name":["Acetaminophen, Diphenhydramine Hydrochloride"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["LEADER/ Cardinal Health 110, Inc."],"package_ndc":["70000-0411-2","70000-0411-1","70000-0411-3"],"product_ndc":["70000-0411"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["4bbe57b4-c0c6-c37f-e063-6294a90a7dd7"],"spl_set_id":["7be4d67e-1af9-f059-e053-2991aa0a382e"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"],"upc":["0096295135299"]},"other_safety_information":["Other information store in a dry place at 15°-30°C (59°-86°F). see end flap for expiration date and lot number."],"overdosage":["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."],"package_label_principal_display_panel":["LEADER TM NDC 70000-0411-3 Extra Strength Acetaminophen PM Acetaminophen, 500 mg Diphenhydramine HCl, 25 mg Pain Reliever/Nighttime Sleep-Aid COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients* 100 CAPLETS Leader label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-231-4670"],"set_id":"7be4d67e-1af9-f059-e053-2991aa0a382e","spl_product_data_elements":["Acetaminophen, Diphenhydramine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride TALC TITANIUM DIOXIDE STEARIC ACID LIGHT MINERAL OIL D&C YELLOW NO. 10 MAGNESIUM STEARATE TRIACETIN FD&C BLUE NO. 1 CROSCARMELLOSE SODIUM CROSCARMELLOSE POVIDONE K30 STARCH, CORN SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYPROMELLOSES SODIUM STARCH GLYCOLATE TYPE A POTATO CPC752"],"spl_unclassified_section":["*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 © 2025 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. 100% Money Back Guarantee Return to place of purchase if not satisfied"],"stop_use":["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. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition."],"version":"7","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. Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients 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 a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery drowsiness will occur 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. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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."],"when_using":["When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery drowsiness will occur"]}