说明与适用边界
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spl product data elements
Pain Relief Extra Strength Acetaminophen 500mg ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSE, UNSPECIFIED POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE WATER G551
活性成分 / Active ingredient
Active ingredient(s) Acetaminophen 500mg
用途 / Purpose
Purpose Pain reliever/fever reducer
适应证 / Indications and usage
Use(s) temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000mg 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. 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 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 Pregnancy/Breastfeeding 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 (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 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
Pregnancy/Breastfeeding ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children Overdose warning: 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 take more than directed (see overdose warning) Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last do not take more than 8 caplets 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
spl unclassified section
Other information do not use if imprinted safety seal under cap is broken or missing
储存 / Storage and handling
Storage store between 20º-25ºC (68º-77ºF)
辅料 / Inactive ingredients
Inactive ingredients corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, purified water*, sodium starch glycolate, stearic acid, titanium dioxide* *may contain these ingredients
questions
Questions Call 1-888-952-0050 Monday to Friday 9am-5pm EST
package label principal display panel
Principal Display Panel Pain Relief Pain Relief
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20210517
- 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.

