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西药 · 美国药品标签原文

Extra strength Acetaminophen PM

ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG

Extra strength Acetaminophen PM · TIME CAP LABS INC。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

Extra strength Acetaminophen PM Acetaminophen 500mg/ Diphenhydramine HCl 25mg SILICON DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE STEARIC ACID MICROCRYSTALLINE CELLULOSE FD&C BLUE NO. 1 ALUMINUM LAKE TITANIUM DIOXIDE CARNAUBA WAX TALC ACETAMINOPHEN ACETAMINOPHEN POVIDONE STARCH, CORN Capsule shaped tablet TCL430

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg

用途 / Purpose

Purpose Pain reliever Nighttime sleep aid

适应证 / Indications and usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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.

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 with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients

咨询医生 / Ask a doctor

Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

使用中 / When using

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

停用事项 / Stop use

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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.

过量 / Overdosage

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.

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 at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

dosage and administration table

<table border="0" width="100%"><tbody><tr><td><content styleCode="bold">adults and children 12 years and over</content></td><td><list listType="unordered"><item>take 2 caplets at bedtime</item><item>do not take more than 2 caplets of this product in 24 hours</item></list></td></tr><tr><td><paragraph><content styleCode="bold">children under 12 years</content></paragraph></td><td><paragraph>do not use</paragraph></td></tr></tbody></table>

其他安全资料 / Other safety information

Other information store between 20-25°C (68-77°F)

辅料 / Inactive ingredients

Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue#1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide **may contain this ingredient

questions

Questions or comments? Call 1-877-290-4008

package label principal display panel

430R-Timely-AcetaminophenPM-400s-Label

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20250721
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