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
up and up ibuprofen pm diphenhydramine citrate and ibuprofen DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 GLYCERYL DIBEHENATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE L050
活性成分 / Active ingredient
Active ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
用途 / Purpose
Purposes Nighttime sleep-aid Pain reliever
适应证 / Indications and usage
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
警告 / Warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • if you have sleeplessness without pain Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers, or any other sleep-aid • under a doctor’s care for any continuing medical illness • taking any other antihistamines • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
禁用事项 / Do not use
Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • if you have sleeplessness without pain
咨询医生 / Ask a doctor
Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • you have trouble urinating due to an enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers, or any other sleep-aid • under a doctor’s care for any continuing medical illness • taking any other antihistamines • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug
使用中 / When using
When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery • take with food or milk if stomach upset occurs
停用事项 / Stop use
Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • redness or swelling is present in the painful area • any new symptoms appear
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
儿童安全 / Keep out of reach of children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 in 24 hours
储存 / Storage and handling
Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68 -77°F) • avoid excessive heat above 40°C (104°F)
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
questions
Questions or comments? 1-888-547-7400
package label principal display panel
Principal Display Panel Compare to active ingredients in Advil® PM Ibuprofen PM Ibuprofen 200 mg / Diphenhydramine Citrate 38 mg Tablets Pain Reliever (NSAID)/Nighttime Sleep-Aid up & up ™ 40 CAPLETS** (**CAPSULE-SHAPED TABLETS) Actual Size 40 Caplets Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 12 / 20260316
- 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.

