说明与适用边界
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spl product data elements
Acetaminophen Extra Strength Acetaminophen AMMONIA FERROSOFERRIC OXIDE SILICON DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C RED NO. 40 GELATIN, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN and Blue with Grey Band J;1
活性成分 / Active ingredient
Drug Facts Active ingredient (in each gelcap) Acetaminophen USP 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: headache muscular aches backache minor pain of arthritis the common cold toothache 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.
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. 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 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 cellspacing="0" cellpadding="0" border="0" width="100%"><col width="50%"/><col width="50%"/><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">adults and children 12 years and over </td><td styleCode="Rrule" valign="top"><list listType="unordered" styleCode="Disc"><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="Lrule Rrule" valign="top">children under 12 years </td><td styleCode="Rrule" valign="top">ask a doctor </td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20° to 25°C (68° to 77°F). Avoid high humidity do not use if printed foil seal under cap is torn or missing
辅料 / Inactive ingredients
Inactive ingredients ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.
questions
Questions or comments? 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton- Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014
package label principal display panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (400 Gelcaps Container Label) Healthy Living ™ Extra Strength For Adults PAIN RELIEF acetaminophen gelcaps 500 mg Pain Reliever/Fever Reducer Rapid Release Gels † Compare to the active ingredients in Extra Strength Tylenol ® Rapid Release Gels DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 400 Gelcaps 500 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20231129
- 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.

