说明与适用边界
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spl product data elements
acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID L484
活性成分 / Active ingredient
Active ingredient (in each caplet) Acetaminophen 500 mg
用途 / Purpose
Purpose Pain reliever/fever reducer
适应证 / Indications and usage
Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • toothache • minor pain of arthritis • the common cold • premenstrual and menstrual cramps • temporarily reduces fever
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you have ever had an allergic reaction to this product or any of its ingredients 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 • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
禁用事项 / Do not use
Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you have ever had an allergic reaction to this product or any of its ingredients
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver disease
咨询医药人员 / Ask a doctor or pharmacist
停用事项 / Stop use
Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present 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.
儿童安全 / Keep out of reach of children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
用法用量原文 / Dosage and administration
Directions • do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
dosage and administration table
<table width="100%"><col width="27%"/><col width="73%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>adults and children 12 years and over </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption>•</caption>take 2 caplets every 6 hours while symptoms last</item><item><caption>•</caption>do not take more than 6 caplets in 24 hours, unless directed by a doctor</item><item><caption>•</caption>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>children under 12 years</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information • store at 20-25°C (68-77°F)
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients
questions
Questions or comments? 1-800-719-9260
package label principal display panel
Principal Display Panel MAJOR ® compare to the active ingredient in Extra Strength Tylenol ® Caplets extra strength acetaminophen acetaminophen 500 mg pain reliever/fever reducer for adults aspirin free 500 caplets actual size major-acetaminophen-container-image.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20260213
- 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.

