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西药 · 美国药品标签原文

tabcin NIGHT

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

tabcin NIGHT · OPMX LLC。此记录对应特定产品,标签收录不代表所有用途获批。

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spl product data elements

tabcin NIGHT Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN AP02

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine

active ingredient table

<table width="75%"><colgroup><col align="left" valign="top" width="60%"/><col align="right" valign="top" width="40%"/></colgroup><thead><tr styleCode="Toprule"><th><content styleCode="italics">Active ingredients (in each Softgels)</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr styleCode="Toprule"><td>Acetaminophen 325 mg</td><td>Pain reliever/Fever reducer</td></tr><tr><td>Dextromethorphan HBr 15 mg</td><td>Cough suppressant</td></tr><tr styleCode="Botrule"><td>Doxylamine succinate 6.25 mg</td><td>Antihistamine</td></tr></tbody></table>

用途 / Purpose

Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine

purpose table

<table width="75%"><colgroup><col align="left" valign="top" width="60%"/><col align="right" valign="top" width="40%"/></colgroup><thead><tr styleCode="Toprule"><th><content styleCode="italics">Active ingredients (in each Softgels)</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr styleCode="Toprule"><td>Acetaminophen 325 mg</td><td>Pain reliever/Fever reducer</td></tr><tr><td>Dextromethorphan HBr 15 mg</td><td>Cough suppressant</td></tr><tr styleCode="Botrule"><td>Doxylamine succinate 6.25 mg</td><td>Antihistamine</td></tr></tbody></table>

适应证 / Indications and usage

Uses Temporarily relieves common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever Runny nose & sneezing

警告 / Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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. 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. Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizer. Taking the thinning drug warfarin When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness 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 Cough comes back or occurs with rash or headache that lasts. New symptoms occur. These could be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for 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. 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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizer. Taking the thinning drug warfarin

使用中 / When using

When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness

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 Cough comes back or occurs with rash or headache that lasts. New symptoms occur. These could be signs of a serious condition.

儿童安全 / Keep out of reach of children

Keep out of reach of children. Keep out of reach of children.

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

用法用量原文 / Dosage and administration

Directions Take only as directed Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 2 softgels with water every 6 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use

dosage and administration table

<table width="75%"><colgroup><col align="left" valign="top" width="50%"/><col align="left" valign="top" width="50%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Rrule">Adults &amp; children 12 yrs &amp; over</td><td>2 softgels with water every 6 hrs</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Children 4 to under 12 yrs</td><td>Ask a doctor</td></tr><tr><td styleCode="Rrule">Children under 4 yrs</td><td>Do not use</td></tr></tbody></table>

储存 / Storage and handling

Other information Store at room temperature

辅料 / Inactive ingredients

Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

questions

Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

package label principal display panel

PRINCIPAL DISPLAY PANEL NDC 69729-153-10 tabcin NIGHT Night-time Relief Cough & Flu/ Tos y Gripe Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Headache/ Dolor de cabeza Fever/ Fiebre Sore Throat/ Dolor de Garganta Sneezing/ Estornudos Runny Nose/ Secreción Nasal Cough/ Tos 10 Softgels/ 10 Cápsulas Blandas de Gel Nightt

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20250717
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.
核对原始来源