INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. Beeswax, carboxymethyl cellulose, D&C Yellow No.10, ethanol, FD&C Blue No.1, gelatin, glycerin, HPMC, light liquid paraffin, PEG 400, purified water, shellac, sorbitol sorbitan solution, soya bean oil, soya lecithin, stearic acid, titanium dioxide.

INDICATIONS & USAGE SECTION.


Uses. temporarily relieves minor aches and pains due to:headachea coldarthritismuscular achestoothachepremenstrual menstrual cramps. headache. cold. arthritis. muscular aches. toothache. premenstrual menstrual cramps.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each softgel)PurposesAcetaminophen 250 mgPain relieverAspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain relieverCaffeine 65 mgPain reliever aid.

DOSAGE & ADMINISTRATION SECTION.


Directions. do not use more than directeddrink full glass of water with each doseadults and children 12 years and over: take softgels every hours; not more than softgels in 24 hourschildren under 12 years: ask doctor. do not use more than directed. drink full glass of water with each dose. adults and children 12 years and over: take softgels every hours; not more than softgels in 24 hours. children under 12 years: ask doctor.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if. you have liver diseasestomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis or kidney diseaseyou are taking diureticyou have asthma. you have liver disease. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis or kidney disease. you are taking diuretic. you have asthma.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are taking. prescription drug for diabetes, gout, or arthritisany other drug, or are under doctors care for any serious condition. prescription drug for diabetes, gout, or arthritis. any other drug, or are under doctors care for any serious condition.

OTC - DO NOT USE SECTION.


Do not use. if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. 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 drug contains acetaminophen, ask doctor or pharmacist.

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 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.


Active ingredients (in each softgel)PurposesAcetaminophen 250 mgPain relieverAspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain relieverCaffeine 65 mgPain reliever aid.

OTC - QUESTIONS SECTION.


Questions or comments. 1-888-333-9792.

OTC - STOP USE SECTION.


Stop use and ask doctor if. an allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better ringing in the ears or loss of hearing occurspainful area is red or swollenpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than daysany new symptoms occurThese could be signs of serious condition.. an allergic reaction occurs. Seek medical help right away.. you experience any of the following signs of stomach bleeding feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better feel faint. vomit blood. have bloody or black stools. have stomach pain that does not get better. ringing in the ears or loss of hearing occurs. painful area is red or swollen. pain gets worse or lasts for more than 10 days. fever gets worse or lasts for more than days. any new symptoms occur.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 80 Softgel Bottle Label. NEWWell at Walgreens NDC 0363-0021-80EXTRA STRENGTHHeadache Relief Softgels Acetaminophen /Aspirin (NSAID) /Caffeine Pain Reliever Pain Reliever Aid 80 SOFTGELSCompare to Excedrin (R) Extra Strength active ingredients PRINCIPAL DISPLAY PANEL 80 Softgel Bottle Label.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. store at 20 25 (68 77 F)close cap tightly after useread all product information before using.. store at 20 25 (68 77 F). close cap tightly after use. read all product information before using.

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:skin reddeningblistersrashIf skin reaction occurs, stop use and seek medical help right away.. skin reddening. blisters. rash. Allergy alert. Aspirin may cause severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shock. hives. facial swelling. asthma (wheezing). shock. Liver warning. This product contains acetaminophen. Severe liver damage may occur if you takemore than caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product. more than caplets in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this producttake more or for longer time than directed. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. take more or for longer time than directed. Caffeine warning. The recommended dose of this product contains about as much caffeine as 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 have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. 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 drug contains acetaminophen, ask doctor or pharmacist.. Ask doctor before use if. you have liver diseasestomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis or kidney diseaseyou are taking diureticyou have asthma. you have liver disease. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis or kidney disease. you are taking diuretic. you have asthma. Ask doctor or pharmacist before use if you are taking. prescription drug for diabetes, gout, or arthritisany other drug, or are under doctors care for any serious condition. prescription drug for diabetes, gout, or arthritis. any other drug, or are under doctors care for any serious condition. Stop use and ask doctor if. an allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better ringing in the ears or loss of hearing occurspainful area is red or swollenpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than daysany new symptoms occurThese could be signs of serious condition.. an allergic reaction occurs. Seek medical help right away.. you experience any of the following signs of stomach bleeding feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better feel faint. vomit blood. have bloody or black stools. have stomach pain that does not get better. ringing in the ears or loss of hearing occurs. painful area is red or swollen. pain gets worse or lasts for more than 10 days. fever gets worse or lasts for more than days. any new symptoms occur. If pregnant or breast-feeding ask health professional before use. It is especially important not to use aspirin during the last 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.