说明与适用边界
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spl product data elements
Daytime Nighttime Severe Cold and Flu acetaminophen, dextromethorphan hbr,guaifenesin,/ acetaminophen, dextromethorphan hbr, doxylamine succinate Daytime Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ACETAMINOPHEN ACETAMINOPHEN GELATIN Nighttime Severe Cold and Flu acetaminophen, dextromethorphan hbr, doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE GELATIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
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Drug Facts
活性成分 / Active ingredient
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg
用途 / Purpose
Purpose Pain reliever/fever reducer Cough suppressant Expectorant
适应证 / Indications and usage
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 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.
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 you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
咨询医药人员 / Ask a doctor or pharmacist
停用事项 / Stop use
Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with 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. 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 take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
dosage and administration table
<table border="0" width="100%"><tbody><tr><td>adults & children 12 yrs & over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td>do not use</td></tr></tbody></table>
储存 / Storage and handling
Other information do not exceed 25°C
辅料 / Inactive ingredients
Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
questions
Questions or comments? Call 1-877-290-4008
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来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20231209
- 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.

