说明与适用边界
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spl product data elements
TYLENOL 8 HR ARTHRITIS PAIN Acetaminophen HYDROXYETHYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A ACETAMINOPHEN ACETAMINOPHEN TYLENOL;ER
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each caplet) Acetaminophen 650 mg
用途 / Purpose
Purpose Pain reliever/fever reducer
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever
警告 / Warnings
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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 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 take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor
dosage and administration table
<table width="50%" 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</td><td styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 2 caplets every 8 hours with water</item><item>swallow whole; do not crush, chew, split or dissolve</item><item>do not take more than 6 caplets in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule">under 18 years of age</td><td><list listType="unordered" styleCode="Square"><item>ask a doctor</item></list></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 hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
questions
Questions or comments? call 1-800-458-2014 (toll-free) or 215-273-8755 (collect)
package label principal display panel
PRINCIPAL DISPLAY PANEL NDC 50580-575-03 TYLENOL ® 8HR ARTHRITIS PAIN Acetaminophen Extended-release tablets Pain Reliever / Fever Reducer For The Temporary Relief Of Minor Arthritis Pain *Capsule-Shaped Bi-Layer Tablets Actual Size 100 Caplets* 650 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
- 3 / 20240909
- 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.

