说明与适用边界
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spl product data elements
Acetaminophen and Diphenhydramine HCL Acetaminophen and Diphenhydramine HCL CELLULOSE, MICROCRYSTALLINE CARNAUBA WAX TITANIUM DIOXIDE CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SILICON DIOXIDE DIPHENHYDRAMINE DIPHENHYDRAMINE STARCH, CORN FD&C BLUE NO. 2 ACETAMINOPHEN ACETAMINOPHEN STEARIC ACID POVIDONE K30 HYPROMELLOSES FD&C BLUE NO. 1 G651
活性成分 / Active ingredient
Active ingredients (in each caplet) Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 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
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
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 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
储存 / Storage and handling
Other information ■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature. ■ see end panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide
questions
Questions or comments? call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
package label principal display panel
Principal display panel 50ct 100ct
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20251219
- 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.

