{"active_ingredient":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid"],"active_ingredient_table":["
Active ingredients (in each caplet)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep aid
"],"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":["
adults and children 12 years and over
take 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hours
children under 12 years
do not use
"],"effective_time":"20250929","id":"3ff37f0e-3a25-dfd8-e063-6394a90ae3ca","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, 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."],"openfda":{"application_number":["M013"],"brand_name":["Pain Relief PM Extra Strength"],"generic_name":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TopCo Associates LLC"],"package_ndc":["36800-095-03","36800-095-17"],"product_ndc":["36800-095"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["3ff37f0e-3a25-dfd8-e063-6394a90ae3ca"],"spl_set_id":["3b672ec7-8658-4b43-a79d-094ac8bc6904"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 36800-095-03 TopCare® Health Compare to Extra Strength Tylenol® PM Active Ingredients* Extra Strength Nighttime Pain Relief PM Acetaminophen 500mg/Diphenhydramine HCl 25 mg Pain Reliever/Fever Reducer • Nighttime Sleep Aid 100 CAPLETS For Adults actual size image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid"],"purpose_table":["
Active ingredients (in each caplet)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep aid
"],"set_id":"3b672ec7-8658-4b43-a79d-094ac8bc6904","spl_product_data_elements":["Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AAA;1031"],"spl_unclassified_section":["Drug Facts"],"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 store between 20-25°C (68-77°F) in a dry place retain carton for complete product information"],"version":"5","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. 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 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 drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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. 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 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."],"when_using":["When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"]}