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spl product data elements
EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 STARCH, CORN STEARIC ACID TALC ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE SODIUM STARCH GLYCOLATE TYPE A POTATO S7
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Drug Facts
活性成分 / Active ingredient
Active ingredient (in each tablet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid
active ingredient table
<table width="50%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr styleCode="First Last"><th align="left"><content styleCode="italics">Active ingredient (in each tablet)</content></th><th align="right"><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td align="left">Acetaminophen 250 mg</td><td align="right">Pain reliever</td></tr><tr><td align="left">Aspirin 250 mg (NSAID) <footnote ID="K404">nonsteroidal anti-inflammatory drug</footnote></td><td align="right">Pain reliever</td></tr><tr><td align="left">Caffeine 65 mg</td><td align="right">Pain reliever aid</td></tr></tbody></table>
用途 / Purpose
Active ingredient (in each tablet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid
purpose table
<table width="50%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr styleCode="First Last"><th align="left"><content styleCode="italics">Active ingredient (in each tablet)</content></th><th align="right"><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td align="left">Acetaminophen 250 mg</td><td align="right">Pain reliever</td></tr><tr><td align="left">Aspirin 250 mg (NSAID) <footnote ID="K404">nonsteroidal anti-inflammatory drug</footnote></td><td align="right">Pain reliever</td></tr><tr><td align="left">Caffeine 65 mg</td><td align="right">Pain reliever aid</td></tr></tbody></table>
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
警告 / 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 Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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 8 tablets 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 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 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. Ask 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 Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug 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 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 3 days any new symptoms appear 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 3 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 Overdose Warning 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. 1(800) 222-1222
禁用事项 / 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.
咨询医生 / Ask a doctor
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug
停用事项 / Stop use
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 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 3 days any new symptoms appear These could be signs of a serious condition
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 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.
儿童安全 / Keep out of reach of children
Keep out of reach of children
用法用量原文 / Dosage and administration
Directions do not use more than directed (see Overdose Warning ) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
储存 / Storage and handling
Other information Each caplet contains: Magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using. Keep this box for important information
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc
questions
Questions or comments 1-888-333-9792
package label principal display panel
PRINCIPAL DISPLAY PANEL COMPARE TO THE ACTIVE INGREDIENTS OF EXCEDRIN® EXTRA STRENGTH* EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHE, ASPIRIN (NSAID) AND CAFFEINE 100 TABLETS HR
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20260116
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

