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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 · Childrens Pain Relief

ACETAMINOPHEN

Childrens Pain Relief · 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

Childrens Pain Relief Acetaminophen ANHYDROUS CITRIC ACID SILICON DIOXIDE COPOVIDONE K25-31 CROSPOVIDONE (120 .MU.M) D&C RED NO. 27 D&C RED NO. 30 DEXTROSE MONOHYDRATE ETHYLCELLULOSE (4 MPA.S) FD&C BLUE NO. 1 MAGNESIUM STEARATE MANNITOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN J26

活性成分 / Active ingredient

Active ingredient (in each tablet) Acetaminophen USP 160 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 flu headache sore throat toothache temporarily reduces fever

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is 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 your child has liver disease.

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

使用中 / When using

When using this product do not exceed recommended dosage.

停用事项 / Stop use

Stop use and ask a doctor if pain gets worse or lasts more than 5 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.

儿童安全 / Keep out of reach of children

Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) find right dose on chart below. If possible, use weight to dose; otherwise, use age chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)* * or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 1 tablet 36-47 4-5 years 1½ tablets 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets

dosage and administration table

<table cellspacing="0" cellpadding="0" border="0" width="69%"><col width="38.76%"/><col width="29.9%"/><col width="31.34%"/><thead><tr><th align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">Weight (lb)</content> </th><th align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">Age (yr)</content> </th><th align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">Dose (tablets)*</content><content styleCode="bold"/> </th></tr></thead><tfoot><tr><td colspan="3">* or as directed by a doctor</td></tr></tfoot><tbody><tr styleCode="Botrule"><td align="center" styleCode="Lrule Rrule" valign="middle">under 24 </td><td align="center" styleCode="Rrule" valign="middle">under 2 years </td><td align="center" styleCode="Rrule" valign="middle">ask a doctor </td></tr><tr styleCode="Botrule"><td align="center" styleCode="Lrule Rrule" valign="middle">24-35 </td><td align="center" styleCode="Rrule" valign="middle">2-3 years </td><td align="center" styleCode="Rrule" valign="middle">1 tablet </td></tr><tr styleCode="Botrule"><td align="center" styleCode="Lrule Rrule" valign="middle">36-47 </td><td align="center" styleCode="Rrule" valign="middle">4-5 years </td><td align="center" styleCode="Rrule" valign="middle">1&#xBD; tablets </td></tr><tr styleCode="Botrule"><td align="center" styleCode="Lrule Rrule" valign="middle">48-59 </td><td align="center" styleCode="Rrule" valign="middle">6-8 years </td><td align="center" styleCode="Rrule" valign="middle">2 tablets </td></tr><tr styleCode="Botrule"><td align="center" styleCode="Lrule Rrule" valign="middle">60-71 </td><td align="center" styleCode="Rrule" valign="middle">9-10 years </td><td align="center" styleCode="Rrule" valign="middle">2&#xBD; tablets </td></tr><tr><td align="center" styleCode="Lrule Rrule" valign="middle">72-95 </td><td align="center" styleCode="Rrule" valign="middle">11 years </td><td align="center" styleCode="Rrule" valign="middle">3 tablets </td></tr></tbody></table>

储存 / Storage and handling

Other information store at 20° to 25°C (68° to 77°F). Avoid high humidity. Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

辅料 / Inactive ingredients

Inactive ingredients citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, FD &C Blue No.1 lake, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose. Questions or comments? Call 1-855-274-4122 * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol ® Chewables. DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648

package label principal display panel

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets) AUROHEALTH NDC 58602-765-76 Ages 2-11 Children's Pain Relief Acetaminophen 160 mg Pain reliever/Fever reducer Aspirin Free Ibuprofen Free Grape Flavor Compare to the active ingredient in Children's Tylenol® Chewables* 24 Chewable Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 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