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西药 · 美国药品标签原文

对乙酰氨基酚 · 对乙酰氨基酚 · TYLENOL Regular Strength

ACETAMINOPHEN

TYLENOL Regular Strength · Kenvue Brands LLC。此记录对应特定产品,标签收录不代表所有用途获批。

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

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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.
核对原始来源