说明与适用边界
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spl product data elements
Acetaminophen and Ibuprofen Acetaminophen and Ibuprofen STEARIC ACID POLYDEXTROSE IBUPROFEN IBUPROFEN FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (3 MPA.S) STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 POVIDONE K30 POVIDONE K90 MAGNESIUM STEARATE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) FERRIC OXIDE RED SODIUM LAURYL SULFATE CARNAUBA WAX HYPROMELLOSE 2910 (15 MPA.S) CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE CROSPOVIDONE G;131 (Light yellow to yellow colored) (capsule shaped, biconvex)
活性成分 / Active ingredient
Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID**) **nonsteroidal anti-inflammatory drug
用途 / Purpose
Purposes Pain reliever Pain reliever
适应证 / Indications and usage
Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
警告 / Warnings
Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 6 caplets in 24 hours, which is the maximum daily amount for this product ■ 3 or more alcoholic drinks every day while using this product
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If skin reaction occurs, stop use and seek medical help right away.
NSAID 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.
NSAID 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 ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ if you have ever had an allergic reaction to acetaminophen or any other pain reliever ■ right before or after heart surgery
咨询医生 / Ask a doctor
Ask a doctor before use if ■ you have liver disease ■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers ■ 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
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product ■ 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 ■ 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 right away. Prompt 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 adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
储存 / Storage and handling
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, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and 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 144ct
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 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.

