DOSAGE & ADMINISTRATION SECTION.


Directions. odo not use more than directedodo not use in children under 12 years of ageoadults and children 12 years of age and over: take caplets at bedtime, with full glass of waterodo not take more than caplets in 24 hours, unless directed by doctor. odo not use more than directed. odo not use in children under 12 years of age. oadults and children 12 years of age and over: take caplets at bedtime, with full glass of water. odo not take more than caplets in 24 hours, unless directed by doctor.

INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. benzoic acid, calcium carbonate, FD&C blue1 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.

INDICATIONS & USAGE SECTION.


Uses. ofor the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness. ofor the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each caplet). Acetaminophen 250 mgAspirin 250 mg (NSAID)Diphenhydramine citrate 38 mgnonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if. oyou have liver diseaseostomach bleeding warning applies to youoyou have history of stomach problems, such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseoyou are taking diureticoyou have asthmaoyou have glaucomaoyou have breathing problem such as emphysema or chronic bronchitisoyou have trouble urinating due to an enlarged prostate gland. oyou have liver disease. ostomach bleeding warning applies to you. oyou have history of stomach problems, such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease. oyou are taking diuretic. oyou have asthma. oyou have glaucoma. oyou have breathing problem such as emphysema or chronic bronchitis. oyou have trouble urinating due to an enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. takingoa prescription drug for:odiabetesogoutoarthritisoany other drug, or are under doctors care for any serious conditionoany product that contains aspirin, acetaminophen, or any other pain reliever/fever reducerosedatives or tranquilizers. oa prescription drug for:odiabetesogoutoarthritis. odiabetes. ogout. oarthritis. oany other drug, or are under doctors care for any serious condition. oany product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer. osedatives or tranquilizers.

OTC - DO NOT USE SECTION.


Do not use. oif you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerowith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.owith any other product containing diphenhydramine, even one used on skinoin children under 12 years of age. oif you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. owith any other product containing diphenhydramine, even one used on skin. oin children under 12 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. In case of overdose, get medical help or contact 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.

OTC - PREGNULLNCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding,. ask 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 doctor because it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION.


Purposes. Pain RelieverPain RelieverNighttime sleep-aid.

OTC - QUESTIONS SECTION.


Questions or comments. 1-800-452-0051.

OTC - STOP USE SECTION.


Stop use and ask doctor if. oan allergic reaction occurs. Seek medical help right away.oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betterosleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.opain gets worse or last for more than 10 daysopainful area is red or swollenoringing in the ears or loss of hearing occursoany new symptoms occurThese could be signs of serious condition. oan allergic reaction occurs. Seek medical help right away.. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get better. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. osleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. opain gets worse or last for more than 10 days. opainful area is red or swollen. oringing in the ears or loss of hearing occurs. oany new symptoms occur.

OTC - WHEN USING SECTION.


When using this product. odrowsiness will occuroavoid alcoholic drinksodo not drive motor vehicle or operate machinery. odrowsiness will occur. oavoid alcoholic drinks. odo not drive motor vehicle or operate machinery.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel. NDC 0067-2056-24EXCEDRIN(R) PM HEADACHEAcetaminophen, Aspirin (NSAID) and Diphenhydramine CitratePain Reliever/Nighttime Sleep-AidTriple Action FormulaCaffeine-FreeNon-Habit Forming24 CAPLETSTAMPER-EVIDENT BOTTLEDO NOT USE IF INNER FOIL SEAL IMPRINTED WITH SEALED for YOUR PROTECTION IS BROKEN OR MISSINGDistributed by: GSK Consumer Healthcare Warren, NJ 07059(C)2015 GSK or its licensor.Visit us at www.excedrin.com46172695. Excedrin PM 24 count carton.

SPL UNCLASSIFIED SECTION.


Other information. ostore at 20-25C (68-77F).oclose cap tightly after use.oread all product information before using. Keep this box for important information.. ostore at 20-25C (68-77F).. oclose cap tightly after use.. oread all product information before using. Keep this box for important information.

WARNINGS SECTION.


Warnings. Reyes 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 doctor because these symptoms could be an early sign of Reyes syndrome, rare but serious illness.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:oskin reddeningoblistersorashIf skin reaction occurs, stop use and seek medical help right away.Allergy alert: Aspirin may cause severe allergic reaction which may include:ohivesofacial swellingoasthma (wheezing)oshockLiver warning: This product contains acetaminophen. Severe liver damage may occur if you takeomore than caplets in 24 hours, which is the maximum daily amountowith other drugs containing acetaminopheno3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youoare age 60 or olderohave had stomach ulcers or bleeding problemsotake blood thinning (anticoagulant) or steroid drugotake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)ohave or more alcoholic drinks every day while using this productotake more or for longer time than directed. oskin reddening. oblisters. orash. ohives. ofacial swelling. oasthma (wheezing). oshock. omore than caplets in 24 hours, which is the maximum daily amount. owith other drugs containing acetaminophen. o3 or more alcoholic drinks every day while using this product. oare age 60 or older. ohave had stomach ulcers or bleeding problems. otake blood thinning (anticoagulant) or steroid drug. otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). ohave or more alcoholic drinks every day while using this product. otake more or for longer time than directed. Do not use. oif you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerowith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.owith any other product containing diphenhydramine, even one used on skinoin children under 12 years of age. oif you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. owith any other product containing diphenhydramine, even one used on skin. oin children under 12 years of age. Ask doctor before use if. oyou have liver diseaseostomach bleeding warning applies to youoyou have history of stomach problems, such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseoyou are taking diureticoyou have asthmaoyou have glaucomaoyou have breathing problem such as emphysema or chronic bronchitisoyou have trouble urinating due to an enlarged prostate gland. oyou have liver disease. ostomach bleeding warning applies to you. oyou have history of stomach problems, such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease. oyou are taking diuretic. oyou have asthma. oyou have glaucoma. oyou have breathing problem such as emphysema or chronic bronchitis. oyou have trouble urinating due to an enlarged prostate gland. Ask doctor or pharmacist before use if you are. takingoa prescription drug for:odiabetesogoutoarthritisoany other drug, or are under doctors care for any serious conditionoany product that contains aspirin, acetaminophen, or any other pain reliever/fever reducerosedatives or tranquilizers. oa prescription drug for:odiabetesogoutoarthritis. odiabetes. ogout. oarthritis. oany other drug, or are under doctors care for any serious condition. oany product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer. osedatives or tranquilizers. When using this product. odrowsiness will occuroavoid alcoholic drinksodo not drive motor vehicle or operate machinery. odrowsiness will occur. oavoid alcoholic drinks. odo not drive motor vehicle or operate machinery. Stop use and ask doctor if. oan allergic reaction occurs. Seek medical help right away.oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betterosleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.opain gets worse or last for more than 10 daysopainful area is red or swollenoringing in the ears or loss of hearing occursoany new symptoms occurThese could be signs of serious condition. oan allergic reaction occurs. Seek medical help right away.. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get better. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. osleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. opain gets worse or last for more than 10 days. opainful area is red or swollen. oringing in the ears or loss of hearing occurs. oany new symptoms occur. If pregnant or breast-feeding,. ask 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 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 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.