{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma • you have glaucoma • you have a breathing problem such as emphysema or chronic bronchitis • you have trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking • a prescription drug for: • diabetes • gout • arthritis • any other drug, or are under a doctor’s care for any serious condition • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer • sedatives or tranquilizers"],"do_not_use":["Do not use • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • 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 use more than directed • do not use in children under 12 years of age • adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water • do not take more than 2 caplets in 24 hours, unless directed by a doctor"],"effective_time":"20240314","id":"8304e801-1a21-42b1-ad99-dd8621be478a","inactive_ingredient":["Inactive ingredients benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate"],"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. 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."],"openfda":{"application_number":["M013"],"brand_name":["Excedrin PM Triple Action Caplets"],"generic_name":["ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"package_ndc":["0067-2056-24","0067-2056-91"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"product_ndc":["0067-2056"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1593110","1593116"],"spl_id":["8304e801-1a21-42b1-ad99-dd8621be478a"],"spl_set_id":["b3812d27-40af-40d7-864a-dfa4ae34cb9e"],"substance_name":["ACETAMINOPHEN","ASPIRIN","DIPHENHYDRAMINE CITRATE"],"unii":["362O9ITL9D","R16CO5Y76E","4OD433S209"]},"package_label_principal_display_panel":["Principal Display Panel EXCEDRIN PM HEADACHE Acetaminophen 250 mg , Aspirin 250 mg (NSAID) and Diphenhydramine Citrate 38 mg Pain Reliever/Nighttime Sleep-Aid Caffeine-Free Non-Habit Forming ACTUAL SIZE 24 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: Haleon, Warren, NJ 07059 ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201994 Excedrin PM Headache 24 ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purposes Pain Reliever Pain Reliever Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-468-7746"],"set_id":"b3812d27-40af-40d7-864a-dfa4ae34cb9e","spl_product_data_elements":["Excedrin PM Triple Action Caplets Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE BENZOIC ACID CALCIUM CARBONATE FD&C BLUE NO. 1 ALUMINUM LAKE FERRIC OXIDE YELLOW HYPROMELLOSE, UNSPECIFIED LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES POLYDEXTROSE POLYSORBATE 80 POVIDONE, UNSPECIFIED STARCH, CORN MICROCRYSTALLINE CELLULOSE STEARIC ACID TALC TITANIUM DIOXIDE ZINC STEARATE light blue oblong shaped tablet EXPM"],"spl_unclassified_section":["Other information • each caplet contains: 75 mg calcium • store at 20°-25°C (68°-77°F). • close cap tightly after use. • read all product information before using. Keep this box for important information."],"stop_use":["Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or last for more than 10 days • painful area is red or swollen • ringing in the ears or a loss of hearing occurs • any new symptoms occur These could be signs of a serious condition"],"version":"9","warnings":["Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Liver warning: This product contains acetaminophen. Severe liver damage may occur 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 Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • 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 • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma • you have glaucoma • you have a breathing problem such as emphysema or chronic bronchitis • you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • a prescription drug for: • diabetes • gout • arthritis • any other drug, or are under a doctor’s care for any serious condition • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer • 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 • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or last for more than 10 days • painful area is red or swollen • ringing in the ears or a loss of hearing occurs • any new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. 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"]}