说明与适用边界
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spl product data elements
XL-3 Night Time acetaminophen, dextromethorphan HBr, Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE PROPYLENE GLYCOL FD&C RED NO. 40 SODIUM BENZOATE SUCRALOSE XANTHAN GUM CITRIC ACID FD&C BLUE NO. 1 ACETAMINOPHEN ACETAMINOPHEN SORBITOL SOLUTION MENTHOL GLYCERIN WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
活性成分 / Active ingredient
Active ingredientes (in each 30mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
用途 / Purpose
Pain reliever/fever reducer Cough Suppressant Antihistamine
适应证 / Indications and usage
Uses temporarily relieves cold/flu symptoms: sore throat headache minor aches and pain fever runny nose and sneezing cough due to minor throat and bronchial irritation
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is sever, persist for more than two 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 products 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleepy
咨询医生 / Ask a doctor
Ask a doctor before use if you have a sodium restricted diet liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs wtih smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness.
停用事项 / Stop use
Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs wih fever, rash or headache that lasts. These could be signs of a serious condition.
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.
过量 / Overdosage
Overdose warning : Taking more than the recommended dose (overdose) may cause serious health problems including liver damage. In case of accidental 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 children even if you do not notice any signs or symptoms.
用法用量原文 / Dosage and administration
take only as recommended- see Overdose warning use only dosing cup provided keep dosing cup provided with the product do not exceed 4 doses per 24 hours if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours TBSP=tablespoon mL=mililiter adults & children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use
dosage and administration table
<table border="1" width="100%"><tbody><tr><td><paragraph> adults & children 12 years and over</paragraph></td><td>30 mL (2 TBSP) every 6 hours</td></tr><tr><td>children 4 to under 12 years</td><td>ask a doctor </td></tr><tr><td> children under 4 years</td><td>do not use </td></tr></tbody></table>
其他安全资料 / Other safety information
Other information each 30 mL contains: sodium 10 mg store between 58° - 86°F (15°-30° degrees C)
辅料 / Inactive ingredients
Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
questions
Questions or Comments? 1-888-446-4753 Monday - Friday from 8 AM - 5 PM Eastern Standard Time
package label principal display panel
XL3-NIGHT TIME 12oz XL-3 NIGTH TIME 6oz
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20260127
- 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.

