说明与适用边界
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spl product data elements
Childrens Pain and Fever Acetaminophen FD&C RED NO. 40 MICROCRYSTALLINE CELLULOSE ACETAMINOPHEN ACETAMINOPHEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID HYDROXYETHYL CELLULOSE, UNSPECIFIED PROPYLPARABEN WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM GLYCERIN SORBITOL SOLUTION SUCROSE
spl unclassified section
Drug Facts
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.
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 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 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 this product does not contain directions or complete warnings for adult use. shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lbs) Age (yr) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
dosage and administration table
<table border="0" width="100%"><tbody><tr><td>Weight (lbs)</td><td>Age (yr)</td><td>Dose (mL)*</td></tr><tr><td>under 24</td><td>under 2</td><td>ask a doctor</td></tr><tr><td>24-35</td><td>2-3 years</td><td>5 mL</td></tr><tr><td>36-47</td><td>4-5 years</td><td>7.5 mL</td></tr><tr><td>48-59</td><td>6-8 years</td><td>10 mL</td></tr><tr><td>60-71</td><td>9-10 years</td><td>12.5 mL</td></tr><tr><td>72-95</td><td>11 years</td><td>15 mL</td></tr></tbody></table>
储存 / Storage and handling
Other information each 5 mL contains: sodium 2 mg store between 20-25° (68-77°F)
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
questions
Questions or comments? Call 1-877-290-4008
package label principal display panel
apap-4oz-label apap-4oz-ifc
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240410
- 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.

