说明与适用边界
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spl product data elements
ACETAMINOPHEN PM Acetaminophen and Diphenhydramine Hydrochloride SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE dark blue and light blue ends G3
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid
active ingredient table
<table width="80%"><col width="50%" align="left" valign="top"/><col width="50%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each gelcap)</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 gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid
purpose table
<table width="80%"><col width="50%" align="left" valign="top"/><col width="50%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each gelcap)</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
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 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use
dosage and administration table
<table width="80%"><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 gelcaps at bedtime</item><item>do not take more than 2 gelcaps 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 20-25ºC (68-77ºF) retain carton for complete product information
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
package label principal display panel
PRINCIPAL DISPLAY PANEL CAREone® NDC 72476-171-03 Compare to the actrive ingredients in Tylenol® PM Extra Strength† Extra Strength ACETAMINOPHEN PM Acetaminophen - Pain Reliever Diphenhydramine HCl - Nighttime Sleep Aid For Adults Actual Size 80 GELCAPS image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240614
- 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.

