说明与适用边界
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spl product data elements
Acetaminophen Acetaminophen SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE STARCH, PREGELATINIZED CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN red and light blue ends G1
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each gelcap) Acetaminophen 500 mg
用途 / Purpose
Purpose Pain reliever/fever reducer
适应证 / Indications and usage
Uses 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 4,000 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. 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. 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
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.
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 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
dosage and administration table
<table width="65%" styleCode="Noautorules"><col width="30%" align="left" valign="top"/><col width="70%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td styleCode="Rrule Toprule">adults and children 12 years and over</td><td styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 2 gelcaps every 6 hours while symptoms last</item><item>do not take more than 6 gelcaps in 24 hours, unless directed by a doctor</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule">children under 12 years</td><td><list listType="unordered" styleCode="Square"><item>ask a doctor</item></list></td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20-25ºC (68-77ºF) retain carton for complete product information
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
package label principal display panel
PRINCIPAL DISPLAY PANEL CAREone® NDC 72476-070-03 Compare to the active ingredient in Tylenol® Extra Strength Rapid Release Gels† Extra Strength ACETAMINOPHEN Pain Reliever / Fever Reducer For adults Actual Size 100 GELCAPS 500 mg EACH image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240614
- 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.

