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spl product data elements
Acetaminophen Acetaminophen ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCROSE ACETAMINOPHEN ACETAMINOPHEN
用途 / Purpose
Purpose Pain reliever/fever reducer
活性成分 / Active ingredient
Active ingredient (in each 10.15 mL cup) Acetaminophen 325 mg
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse If pregnant or breast-feeding, ask a health professional before use. 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 for adults as well as children 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of this product
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver disease
咨询医药人员 / Ask a doctor or pharmacist
停用事项 / Stop use
Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children.
用法用量原文 / Dosage and administration
Directions do not take more than directed (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 6 years of age consult a doctor
dosage and administration table
<table width="100%"><col width="50%"/><col width="50%"/><thead><tr><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">age</content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">dose</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule " valign="top"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode="Rrule Toprule " valign="top"><paragraph>20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 6 to under 12 years of age</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>children under 6 years of age</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>consult a doctor</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information Each 10.15 mL contains: sodium 4 mg store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] protect from light a red, cherry flavored solution supplied in the following oral dosage forms: 10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56
辅料 / Inactive ingredients
Inactive ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.
questions
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.
spl unclassified section
DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R03/23
package label principal display panel
Principal Display Panel – Tray Label Case NDC 60687-751-56/Cup NDC 60687-751-42 ACETAMINOPHEN ORAL SOLUTION USP 325 mg/10.15 mL ALCOHOL FREE Each 10.15 mL contains: Acetaminophen 325 mg USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. For Institutional Use Only. T0657C110323 R03/23 Tray Label
Principal Display Panel – Cup – 325 mg / 10.15 mL NDC 60687- 751 -42 ACETAMINOPHEN ORAL SOLUTION USP Pain Reliever/Fever Reducer 325 mg/10.15 mL ALCOHOL FREE Delivers 10.15 mL Protect from light. See packaging Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0657C110323 325 mg/10.15 mL Acetaminophen Oral Solution Cup
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241021
- 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.

