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spl product data elements
Acetaminophen Acetaminophen STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO 54;27
活性成分 / Active ingredient
Drug Facts Active Ingredient (in each tablet) Acetaminophen 500 mg
用途 / Purpose
Purpose Pain reliever/ Fever reducer
适应证 / Indications and usage
Uses Temporarily reduces fever and relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps
警告 / 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. 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 are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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
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 are allergic to acetaminophen or any of the inactive ingredients in this product
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver disease
咨询医药人员 / Ask a doctor or pharmacist
停用事项 / Stop use
Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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.
过量 / Overdosage
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.
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 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
其他安全资料 / Other safety information
Other Information store in a dry place at 15° – 30°C (59° – 86°F).
辅料 / Inactive ingredients
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
questions
Questions or comments? Call 1-800-231-4670
spl unclassified section
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
包装供应 / How supplied
HOW SUPPLIED Product: 50090-5313 NDC: 50090-5313-1 30 TABLET in a BOTTLE NDC: 50090-5313-2 100 TABLET in a BOTTLE NDC: 50090-5313-3 50 TABLET in a BOTTLE NDC: 50090-5313-4 24 TABLET in a BOTTLE
package label principal display panel
Acetaminophen Label Image
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 9 / 20250424
- 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.

