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spl product data elements
AMAZON BASIC CARE IBUPROFEN PM Ibuprofen and Diphenhydramine Citrate IBUPROFEN IBUPROFEN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 GLYCERYL DIBEHENATE HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 PALMITIC ACID POLYDEXTROSE POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TITANIUM DIOXIDE DI;200
活性成分 / Active ingredient
Drug Facts Active ingredients (in each caplet) Diphenhydramine citrate USP 38 mg Ibuprofen USP 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.
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 reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 Other information read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N., SEATTLE, WA 98109 Made in India
package label principal display panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets actual size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20260318
- 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.

