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西药 · 美国药品标签原文

对乙酰氨基酚 · 对乙酰氨基酚 · Acetaminophen Extra Strength

ACETAMINOPHEN

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

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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.
核对原始来源