{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 500 mg* Diphenhydramine HCl 25 mg**"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you have liver disease asthma breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urinating due to an enlargement of the prostate gland","Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin"],"do_not_use":["Do not use with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in children under 12 years of age with other products containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions do not exceed recommended dose adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours. children under 12 years of age: 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":"20100205","id":"691c5587-3994-45e2-a669-608ba7a98bfb","inactive_ingredient":["Inactive ingredients FD&C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide."],"indications_and_usage":["Uses Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 63548-2341-*1 SEE NEW WARNINGS INFORMATION EXTRA STRENGTH Pain Relief PM Pain reliever Nighttime Sleep-Aid Acetaminophen 500 mg Diphenhydramine HCl 25 mg 24 CAPLETS Do not use if imprinted safety seal under cap is broken or missing Pain Relief PM Packaging Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health care professional before use. Keep out of reach of children."],"purpose":["Purpose *Pain reliever **Nighttime sleep aid"],"set_id":"691c5587-3994-45e2-a669-608ba7a98bfb","spl_product_data_elements":["Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ALCOHOL POVIDONE K30 CARBOXYMETHYLCELLULOSE SODIUM STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE V15"],"spl_unclassified_section":["Other information store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat do not use if imprinted safety seal under cap is broken or missing"],"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. pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take: more than 2 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not use with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in children under 12 years of age with other products containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease asthma breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urinating due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery. This product will cause drowsiness. 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. pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present If pregnant or breast-feeding , ask a health care professional before use. Keep out of reach of children."],"when_using":["When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery. This product will cause drowsiness."]}