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西药 · 美国药品标签原文

pain relief PM

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

pain relief PM · HARRIS TEETER。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

pain relief PM Acetaminophen and Diphenhydramine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE AAA;1031

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid

active ingredient table

<table width="60%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each caplet) </content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Acetaminophen 500 mg</td><td>Pain reliever</td></tr><tr><td>Diphenhydramine HCl 25 mg</td><td>Nighttime sleep aid</td></tr></tbody></table>

用途 / Purpose

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid

purpose table

<table width="60%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each caplet) </content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Acetaminophen 500 mg</td><td>Pain reliever</td></tr><tr><td>Diphenhydramine HCl 25 mg</td><td>Nighttime sleep aid</td></tr></tbody></table>

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. 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 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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. 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. 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.

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 width="70%"><col width="30%" align="left" valign="top"/><col width="70%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td align="left" styleCode="Rrule Toprule">adults and children 12 years and over</td><td align="left" styleCode="Toprule"><list listType="unordered" styleCode="Square"><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 align="left" styleCode="Rrule">children under 12 years</td><td align="left"><list listType="unordered" styleCode="Square"><item>do not use</item></list></td></tr></tbody></table>

储存 / Storage and handling

Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

questions

Questions or comments? 1-844-705-4384

package label principal display panel

PRINCIPAL DISPLAY PANEL Harris Teeter® NDC 72036-05-03 Compare to the active ingredients in Tylenol® PM Extra Strength Caplets† EXTRA STRENGTH ACTAMINOPHEN PM ACETAMINOPHEN, DIPHENHYDRAMINE HCl PAIN RELIEVER/PAIN RELIEVER AID Contains No Aspirin • FOR ADULTS • Actual Size 100 CAPLETS image description

来源、版本与许可

资料类型
美国药品标签原文
版本
6 / 20260805
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