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spl product data elements
Childrens Pain and Fever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM
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 temporarily 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 non-prescription). 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 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 dosage (see overdose warning) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. 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 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 non-prescription). 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 (see overdose warning)
停用事项 / Stop use
Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days 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 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 take more than directed (see overdose warning) shake well before using mL = milliliter use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose; otherwise, use age. Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 mL 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor
dosage and administration table
<table><col/><col/><col/><tbody><tr><td align="center" styleCode=" Botrule Toprule Lrule"><content styleCode="bold">Weight (lb)</content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Age (year)</content></td><td styleCode=" Botrule Toprule Rrule"><content styleCode="bold">Dose (mL)*</content></td></tr><tr><td align="center" styleCode=" Botrule Lrule"> under 24</td><td align="center" styleCode=" Botrule Lrule Rrule"> under 2</td><td styleCode=" Botrule Rrule"> ask a doctor</td></tr><tr><td align="center" styleCode=" Botrule Lrule"> 24-35</td><td align="center" styleCode=" Botrule Lrule Rrule"> 2-3</td><td styleCode=" Botrule Rrule"> 5 mL </td></tr><tr><td align="center" styleCode=" Botrule Lrule"> 36-47</td><td align="center" styleCode=" Botrule Lrule Rrule"> 4-5</td><td styleCode=" Botrule Rrule"> 7.5 mL </td></tr><tr><td align="center" styleCode=" Botrule Lrule"> 48-59</td><td align="center" styleCode=" Botrule Lrule Rrule"> 6-8</td><td styleCode=" Botrule Rrule"> 10 mL</td></tr><tr><td align="center" styleCode=" Botrule Lrule"> 60-71</td><td align="center" styleCode=" Botrule Lrule Rrule"> 9-10</td><td styleCode=" Botrule Rrule"> 12.5 mL</td></tr><tr><td align="center" styleCode=" Botrule Lrule"> 72-95</td><td align="center" styleCode=" Botrule Lrule Rrule"> 11</td><td styleCode=" Botrule Rrule"> 15 mL </td></tr></tbody></table>
储存 / Storage and handling
Other information each 5 mL contains : sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
package label principal display panel
Principal Display Panel Compare to the active ingredient in Children's Tylenol® Oral Suspension** Oral Suspension Children's Pain and Fever ACETAMINOPHEN 160 mg/5 mL Pain reliever; Fever reducer Ages 2 to 11 Years Free of: alcohol, aspirin, ibuprofen & gluten Grape flavor Dosage Cup Included FL OZ (mL) IMPORTANT: Please see dosing chart or ask a doctor for your child's correct dose. **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Product Label CVS HEALTH Children's Pain and Fever Grape Flavor Acetaminophen 160 mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240315
- 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.

