说明与适用边界
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spl product data elements
Tylenol Extra Strength Acetaminophen SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID POVIDONE TITANIUM DIOXIDE CROSPOVIDONE FD&C RED NO. 40 FD&C YELLOW NO. 6 GUAR GUM HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN POWDERED CELLULOSE MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN SUCRALOSE TALC TYLENOL;500
spl unclassified section
Drug Facts
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: the common cold headache backache minor pain of arthritis toothache muscular aches 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 are allergic to acetaminophen or any of the inactive ingredients in this product 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 are allergic to acetaminophen or any of the inactive ingredients in this product
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.
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="60%" styleCode="Noautorules"><colgroup><col align="left" valign="top" width="30%"/><col align="left" valign="top" width="70%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Toprule Rrule">adults and children 12 years and over</td><td styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 2 caplets every 6 hours while symptoms last</item><item>do not take more than 6 caplets in 24 hours, unless directed by a doctor</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule">children under 12 years</td><td>ask a doctor</td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
辅料 / Inactive ingredients
Inactive ingredients crospovidone, FD&C red no. 40, FD&C yellow no. 6, guar gum, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
questions
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
package label principal display panel
PRINCIPAL DISPLAY PANEL NDC 50580-472-01 Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever Fever Reducer EASY TO SWALLOW* With Gentleglide™ Coating Technology Actual Size 24 Caplets 500 mg each tylenol-1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241107
- 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.

