说明与适用边界
此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。
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
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">1½ 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">2½ 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.

