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西药 · 美国药品标签原文

Pain Reliever PM Extra Strength

ACETAMINOPHEN, DIPHENHYDRAMINE HCL

Pain Reliever PM Extra Strength · L.N.K. International, 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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID TALC TITANIUM DIOXIDE 44;235

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. Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age 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 have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness will occur 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 a serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 product containing diphenhydramine, even one used on skin in children under 12 years of age 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 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 a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma difficulty in urination due to enlargement of the prostate gland

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 avoid alcoholic beverages drowsiness will occur 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 a serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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

储存 / Storage and handling

Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

questions

Questions or comments? 1-800-426-9391

package label principal display panel

Principal Display Panel QUALITY +PLUS NDC 50844-235-15 *Compare to active ingredients in Extra Strength Tylenol® PM EXTRA STRENGTH PAIN RELIEVER PM Acetaminophen, Diphenhydramine HCl PAIN RELIEVER/NIGHTTIME SLEEP-AID 50 Caplets Non-habit Forming ACTUAL SIZE Quality Plus 44-235 Quality Plus 44-235

来源、版本与许可

资料类型
美国药品标签原文
版本
16 / 20260727
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