说明与适用边界
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spl product data elements
TYLENOL Regular Strength acetaminophen CARNAUBA WAX STARCH, CORN FD&C RED NO. 40 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POWDERED CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE TYPE A ACETAMINOPHEN ACETAMINOPHEN White with red print Tylenol;325
spl unclassified section
Drug Facts
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.
活性成分 / Active ingredient
Active ingredient (in each caplet) Acetaminophen 325 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 minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
警告 / Warnings
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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 the user has liver disease is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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.
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 the user has liver disease is a child with pain of arthritis
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 in adults pain gets worse or lasts more than 5 days in children under 12 years 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 4 to 6 hours while symptoms last do not take more than 10 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 caplet every 4 to 6 hours while symptoms last do not take more than 5 caplets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor
dosage and administration table
<table width="65%" styleCode="Noautorules"><col width="20%" align="left" valign="top"/><col width="80%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td styleCode="Rrule">adults and children 12 years and over</td><td><list listType="unordered" styleCode="Square"><item>take 2 caplets every 4 to 6 hours while symptoms last</item><item>do not take more than 10 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 styleCode="Botrule"><td styleCode="Rrule">children 6 years to under 12 years</td><td><list listType="unordered" styleCode="Square"><item>take 1 caplet every 4 to 6 hours while symptoms last</item><item>do not take more than 5 caplets in 24 hours</item><item>do not use for more than 5 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule">children under 6 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 blister unit is torn or broken
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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 325mg NDC 50580-458-11 To re-order reference the NDC Code TYLENOL ® Acetaminophen Pain Reliever - Fever Reducer Regular Strength 100 Caplets 325 mg each 10 Blister Cards with 10 Individual Blisters SMART PACKAGING DESIGNED FOR HEALTH CARE PROFESSIONALS FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT. tylenol-1.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 10 / 20260126
- 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.

