说明与适用边界
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spl product data elements
Tylenol Extra Strength Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX STARCH, CORN FD&C RED NO. 40 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POWDERED CELLULOSE PROPYLENE GLYCOL SHELLAC SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE RED PRINT 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"><col width="30%" align="left" valign="top"/><col width="70%" align="left" valign="top"/><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 pouch is torn or damaged
辅料 / Inactive ingredients
Inactive ingredients carnauba wax contains one or more of these ingredients , corn starch , FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch , polyethylene glycol , powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, 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 50580-937-50 TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever Fever Reducer Extra Strength 50 Pouches of 2 Caplets each 500 mg each 50 Pouches of 2 Caplets each – 500 mg each tylenol-1.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 16 / 20260722
- 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.

