说明与适用边界
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spl product data elements
PANADOL PM acetaminophen and diphenhydramine HCl CARNAUBA WAX CROSPOVIDONE (120 .MU.M) FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Caplet PM
活性成分 / Active ingredient
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
用途 / Purpose
Purposes 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 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 are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks be careful when driving a motor vehicle or operating 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. pain gets worse or lasts more than 10 days redness or swelling is present any new symptoms appear 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: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
不良反应 / Adverse reactions
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 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 you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product drowsiness will occur avoid alcoholic drinks be careful when driving a motor vehicle or operating 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. pain gets worse or lasts more than 10 days redness or swelling is present any new symptoms appear 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: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 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 of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor do not give to children under 12 years of age
储存 / Storage and handling
Other information store below 25°C (77°F)
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
questions
Questions or comments? 1-800-455-7139
package label principal display panel
Principal Display Panel NDC 0135-0608-01 PANADOL EXTRA STRENGTH PM ACETAMNOPHEN Pain Reliever DIPHENHYDRAMINE HCl Nighttime Sleep-Aid 24 CAPLETS Tamper-Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken. READ AND KEEP CARTON FOR COMPLETE INFORMATION Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2016 GSK group of companies or its licensor. 101639XE 101639XE_Panadol PM_24 ct.JPG
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20240206
- 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.

