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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 · Infants Pain Relief

ACETAMINOPHEN

Infants Pain Relief · Publix Super Markets Inc。此记录对应特定产品,标签收录不代表所有用途获批。

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spl product data elements

Infants Pain Relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID CALCIUM SULFATE, UNSPECIFIED FORM CARRAGEENAN GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE SORBITOL SUCRALOSE SODIUM PHOSPHATE, TRIBASIC

活性成分 / Active ingredient

Active ingredient (in each 5 mL) Acetaminophen 160 mg

用途 / Purpose

Purpose Pain reliever/fever reducer

适应证 / Indications and usage

Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

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. 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 has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) 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. 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 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 your child has ever had an allergic reaction to this product or any of its ingredients

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 dose (see overdose warning)

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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical 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) • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL * or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

dosage and administration table

<table width="100%"><col width="23%"/><col width="20%"/><col width="24%"/><tbody><tr><td align="center" colspan="3" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Dosing Chart</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Weight (lb)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Age (yr)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Dose (mL)*</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>under 24</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>under 2 years</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>24-35</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>2-3 years</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>5 mL</paragraph></td></tr></tbody></table>

储存 / Storage and handling

Other information • store at 68-77 ° F (20-25 ° C) • do not use if printed neckband is broken or missing

辅料 / Inactive ingredients

Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

package label principal display panel

Package/Label Principal Display Panel P FOR AGES 2-3 YEARS INFANTS’ pain relief ACETAMINOPHEN 160 mg PER 5 mL PAIN RELIEVER/FEVER REDUCER SUSPENSION LIQUID • Ibuprofen free • Alcohol free • Aspirin free • Paraben free GRAPE FLAVOR NO HIGH FRUCTOSE CORN SYRUP USE ONLY WITH ENCLOSED SYRINGE. DYE-FREE PEDIATRICIAN PREFERRED DOSING SYSTEM SEE SIDE PANEL FOR MORE INFORMATION. 2 FL OZ (59 mL) †Compare to Infants’ Tylenol ® Oral Suspension active ingredient 766-63-pain-relief

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20241031
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