DOSAGE & ADMINISTRATION SECTION.
Directions. do not use more than directedadults: take geltabs with glass of waterif symptoms persist or worsen, ask your doctordo not take more than geltabs in 24 hours, unless directed by doctorunder 18 years of age: ask doctor. do not use more than directed. adults: take geltabs with glass of water. if symptoms persist or worsen, ask your doctor. do not take more than geltabs in 24 hours, unless directed by doctor. under 18 years of age: ask doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. benzoic acid, D&C yellow 10 aluminum lake, disodium EDTA, FD&C blue 1, FD&C blue aluminum lake, FD&C red 40 aluminum lake, ferric oxide, gelatin, glycerin, hydroxypropylcellulose, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Use. treats migraine. treats migraine.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each GelTab). Acetaminophen 250 mgAspirin 250 mg (NSAID)Caffeine 65 mgnonsteroidal anti-inflammatory drug.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor before use if. you have never had migraines diagnosed by health professionalyou have headache that is different from your usual migrainesyou have the worst headache of your lifeyou have fever and stiff neckyou have headaches beginning after or caused by head injury, exertion, coughing or bendingyou experienced your first headache after the age of 50you have daily headachesyou have migraine so severe as to require bed restyou 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 asthmayou have problems or serious side effects from taking pain relievers or fever reducersyou have vomiting with your migraine headache. you have never had migraines diagnosed by health professional. you have headache that is different from your usual migraines. you have the worst headache of your life. you have fever and stiff neck. you have headaches beginning after or caused by head injury, exertion, coughing or bending. you experienced your first headache after the age of 50. you have daily headaches. you have migraine so severe as to require bed rest. 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. you have problems or serious side effects from taking pain relievers or fever reducers. you have vomiting with your migraine headache.
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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.
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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.
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OTC - PREGNANCY 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.
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OTC - PURPOSE SECTION.
Purposes. Pain relieverPain relieverPain reliever aid.
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OTC - QUESTIONS SECTION.
Questions. 1-800-452-0051.
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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 your migraine is not relieved or worsens after first dosenew or unexpected symptoms occurringing in the ears or loss of hearing occurs. 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. your migraine is not relieved or worsens after first dose. new or unexpected symptoms occur. ringing in the ears or loss of hearing occurs.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. 0067-2035-20See new warnings informationExcedrin(R)MigraineAcetaminophen, Aspirin (NSAID) and CaffeinePain reliever Pain Reliever Aid20GELTABS GELATIN COATED TABLETSTAMPER-EVIDENT BOTTLEDO NOT USE IF INNER FOIL SEAL IMPRINTED WITH SEALED for YOUR PROTECTION IS BROKEN OR MISSINGDistributed by: GSK Consumer HealthcareWarren, NJ 07059 (C)2017 GSK or its licensor.Visit us at www.excedrin.com62000000012939. 62000000012939Excedrin Geltabs20 ct.JPG.
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SPL UNCLASSIFIED SECTION.
Other information. store at controlled room temperature 20-25C (68-77F)close cap tightly after useread all product information before using. Keep this box for important information.. store at controlled room temperature 20-25C (68-77F). close cap tightly after use. read all product information before using. Keep this box for important information.
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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.Allergy alert:Aspirin may cause severe allergic reaction which may include: hivesfacial swellingasthma (wheezing)shockLiver warning:This product contains acetaminophen. Severe liver damage may occur if you take more than geltabs in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 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 you are 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 directedMedication overuse headache warning:Headaches may worsen if this product is used for 10 or more days per month. 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. skin reddening. blisters. rash. hives. facial swelling. asthma (wheezing). shock. more than geltabs in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this product. 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. 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 never had migraines diagnosed by health professionalyou have headache that is different from your usual migrainesyou have the worst headache of your lifeyou have fever and stiff neckyou have headaches beginning after or caused by head injury, exertion, coughing or bendingyou experienced your first headache after the age of 50you have daily headachesyou have migraine so severe as to require bed restyou 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 asthmayou have problems or serious side effects from taking pain relievers or fever reducersyou have vomiting with your migraine headache. you have never had migraines diagnosed by health professional. you have headache that is different from your usual migraines. you have the worst headache of your life. you have fever and stiff neck. you have headaches beginning after or caused by head injury, exertion, coughing or bending. you experienced your first headache after the age of 50. you have daily headaches. you have migraine so severe as to require bed rest. 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. you have problems or serious side effects from taking pain relievers or fever reducers. you have vomiting with your migraine headache. Ask doctor or pharmacist before use if you are. taking prescription drug for: diabetesgoutarthritis under doctors care for any serious conditiontaking any other drugtaking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer. taking prescription drug for: diabetesgoutarthritis diabetes. gout. arthritis. under doctors care for any serious condition. taking any other drug. taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer. 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 your migraine is not relieved or worsens after first dosenew or unexpected symptoms occurringing in the ears or loss of hearing occurs. 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. your migraine is not relieved or worsens after first dose. new or unexpected symptoms occur. ringing in the ears or loss of hearing occurs. 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.
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