{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 325 mg","Active ingredients (in each caplet) Diphenhydramine HCl 50 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. in children under 12 years of age with any other product containing diphenhydramine, even one used on skin 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 older: • take 1 caplet at bedtime • do not take more than 1 caplet of this product in 24 hours children under 12 years: do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage"],"effective_time":"20260114","id":"75e0be81-2c6a-461a-9da5-c2aa060e2dc8","inactive_ingredient":["Inactive ingredients blue 1 lake, croscarmellose sodium, dicalcium phosphate, hydroxypropylcellulose, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, PVP, silica, sodium carboxymethyl starch, stearic acid (283-056)"],"indications_and_usage":["Uses for the 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":["Unisom PM Pain Nighttime Sleep Aid and Pain Reliever"],"generic_name":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0040-2","41167-0040-3","41167-0040-4"],"product_ndc":["41167-0040"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1093075","1093077"],"spl_id":["75e0be81-2c6a-461a-9da5-c2aa060e2dc8"],"spl_set_id":["451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Unisom ® PM PAIN SLEEPCAPS TM 30 Caplets Unisom® PM PAIN SLEEPCAPSTM 30 Caplets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever","Purposes Nighttime sleep-aid"],"set_id":"451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb","spl_product_data_elements":["Unisom PM Pain Nighttime Sleep Aid and Pain Reliever Acetaminophen and Diphenhydramine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL STARCH, CORN POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID White and blue UNISOM;PM;PAIN"],"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 medical illness. pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition."],"version":"9","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 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. in children under 12 years of age with any other product containing diphenhydramine, even one used on skin 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 medical illness. pain gets worse or lasts for more than 10 days fever gets worse or lasts for 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. O verdose 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. 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"]}