{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug","Active Ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg"],"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 a doctor before use if • you have liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking • a prescription drug for: o diabetes o gout o 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","Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"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","Do not use • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"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","Directions • do not use more than directed • adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years: ask a doctor"],"effective_time":"20240314","id":"5b0f5eff-6fa1-4334-a51c-fd79e54e209b","inactive_ingredient":["Inactive ingredients benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate","Inactive Ingredients benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness","Uses • temporarily relieves minor aches and pain due to: o headache muscular aches"],"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.","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 and Excedrin Tension Headache"],"generic_name":["ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-8147-01","0067-2056-24","0067-8139-02"],"product_ndc":["0067-8147"],"product_type":["HUMAN OTC DRUG"],"rxcui":["307686","404172","1593110","1593116"],"spl_id":["5b0f5eff-6fa1-4334-a51c-fd79e54e209b"],"spl_set_id":["978a9d27-6d41-42cb-a193-11314923d2ac"]},"package_label_principal_display_panel":["Principal Display Panel (Excedrin PM Headache) DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED. NDC 0067-2056-24 EXCEDRIN ® PM HEADACHE Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate Pain Reliever/Nighttime Sleep-Aid Triple Action Formula Caffeine-Free Non-Habit Forming 24 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2015 GSK or its licensor. Visit us at www.excedrin.com 46172695 Excedrin PM 24 count carton","Principal Display Panel (Excedrin Tension Headache) NDC 0067-8139-02 EXCEDRIN ® TENSION HEADACHE Acetaminophen and Caffeine Pain Reliever / Pain Reliever Aid Aspirin Free 100 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies Visit us at www.excedrin.com 46177300 46177300_Excedrin Tension Headache_100 ct.JPG"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain Reliever Pain Reliever Nighttime sleep-aid","Purpose s Pain reliever Pain reliever aid"],"questions":["Questions or comments? 1-800-452-0051","Questions or comments? 1-800-452-0051"],"set_id":"978a9d27-6d41-42cb-a193-11314923d2ac","spl_product_data_elements":["Excedrin PM Triple Action Caplets and Excedrin Tension Headache Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate 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 LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES POLYDEXTROSE POLYSORBATE 80 POVIDONE, UNSPECIFIED STARCH, CORN MICROCRYSTALLINE CELLULOSE STEARIC ACID TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW ZINC STEARATE light blue EXPM Excedrin Tension Headache Acetaminophen, Caffeine ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE BENZOIC ACID D&C RED NO. 27 ALUMINUM LAKE FD&C BLUE NO. 2 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TALC (Caplet) ETH"],"spl_unclassified_section":["Excedrin PM Headache","Other information • 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.","Excedrin Tension Headache","Other information • 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: o feel faint o vomit blood o have bloody or black stools o 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","Stop use and ask a doctor if • any new symptoms occur • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days These could be signs of a serious condition"],"version":"5","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: o diabetes o gout o 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: o feel faint o vomit blood o have bloody or black stools o 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 during the last three months of 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.","Warnings 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. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 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 Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat Do not use • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if • any new symptoms occur • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for 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. 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"]}