说明与适用边界
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spl product data elements
Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN TALC TITANIUM DIOXIDE P525
活性成分 / Active ingredient
Active Ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine 25 mg
用途 / Purpose
Purpose Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................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 hrs ■ 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 ■ 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 ■ 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 Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) 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 and over ■ take 2 caplets at bedtime ■ do not take more than 2 caplets in 24 hours unless directed by a doctor ■ children under 12 years do not use
其他安全资料 / Other safety information
Other Information: store at 20°-25°C (68°-77°F) do not use if foil or inner seal is broken or missing
辅料 / Inactive ingredients
Inactive Ingredients: Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2 Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide.
questions
Questions or Comments? Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com
spl unclassified section
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Tablets. Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816
package label principal display panel
Rev 00 Pain Relief PM ES 375cts-PRINT
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20251229
- 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.

