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西药 · 美国药品标签原文

AGRIFEN

ACETAMINOPHEN, ASPIRIN, CAFFEINE

AGRIFEN · OPMX LLC。此记录对应特定产品,标签收录不代表所有用途获批。

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spl product data elements

AGRIFEN Acetaminophen, aspirin, caffeine HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE SODIUM STARCH GLYCOLATE TYPE B PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID CROSPOVIDONE TITANIUM DIOXIDE STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE ASPIRIN ASPIRIN S53 Capsule shape

spl unclassified section

Drug facts Other information store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Read & Keep Outer Carton for Complete Product Information

活性成分 / Active ingredient

Active ingredients (in each caplets) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

用途 / Purpose

Acetaminophen 250 mg ........Pain reliever Aspirin 250 mg (NSAID)*........Pain reliever Caffeine 65 mg.......................Pain reliever aid *nonsteroidal anti-inflammatory drug

适应证 / Indications and usage

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps

警告 / Warnings

Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, wich is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and, occasionally, rapid heartbeat. Do not use if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away any new symptoms appear ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days painful area is red or swollen If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition

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 have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away any new symptoms appear ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days painful area is red or swollen

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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.

过量 / Overdosage

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 use more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor

辅料 / Inactive ingredients

Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

package label principal display panel

PRINCIPAL DISPLAY PANEL - 12 Caplets NDC 69729-159-12 AGRIFEN Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg Desinflama y alivia el dolor de: Fiebre-Cabeza-Dental Relief inflammation and pains of: Fver-Headache-Toothache 12 Caplets Ag12

来源、版本与许可

资料类型
美国药品标签原文
版本
1 / 20240126
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.
核对原始来源