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西药 · 美国药品标签原文

Daytime Severe and Nighttime Severe cold and flu

DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL

Daytime Severe and Nighttime Severe cold and flu · TARGET CORPORATION。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

Daytime Severe and Nighttime Severe cold and flu Daytime Severe - Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Nighttime Severe-Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl Nighttime severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POLYETHYLENE GLYCOL, UNSPECIFIED clear Daytime severe cold and flu Acetaminophen,Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SORBITOL POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN SODIUM BENZOATE CITRIC ACID MONOHYDRATE SODIUM CHLORIDE SODIUM CITRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE clear

活性成分 / Active ingredient

Nighttime Severe Cold & Flu Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg Daytime Severe Cold & Flu Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

用途 / Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation minor aches and pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage 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 4 doses 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. 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 heart disease high blood pressure thyroid disease diabetes 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 a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed 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, and tranquilizers may increase drowsiness Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product taken 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. 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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. 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 heart disease high blood pressure thyroid disease diabetes 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 a sodium-restricted diet Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium-restricted diet

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

使用中 / When using

When using this product do not use more than directed 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, and tranquilizers may increase drowsiness When using this product do not use more than directed

停用事项 / Stop use

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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. Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

dosage and administration table

<table width="100%"><colgroup><col width="48%"/><col width="52%"/></colgroup><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>adults &amp; children 12 yrs &amp; over</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>30 mL every 4 hrs</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>children 4 to under 12 yrs</paragraph></td><td styleCode="Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Toprule " valign="top"><paragraph>children under 4 yrs</paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table> <table width="100%"><colgroup><col width="51%"/><col width="46%"/></colgroup><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>adults &amp; children 12 yrs &amp; over</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>30 mL every 4 hrs</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>children 6 to under 12 yrs</paragraph></td><td styleCode="Lrule Toprule Botrule " valign="top"><paragraph>15 mL every 4 hrs</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>children 4 to under 6 yrs</paragraph></td><td styleCode="Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>children under 4 yrs</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table>

储存 / Storage and handling

Other information each 30 mL contains: sodium 98 mg store at no greater than 25℃ and do not refrigerate Other information each 15 mL contains: sodium 56 mg store at no greater than 25℃ and do not refrigerate

辅料 / Inactive ingredients

Inactive ingredients citric acid monohydrate, FD&C blue no.1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum Inactive ingredients citric acid monohydrate, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

questions

Questions or comments? Call 1-800-910-6874 Questions or comments? Call 1-800-910-6874

package label principal display panel

Principal Display Panel daytime-nighttime-severe-label nighttime-severe-label daytime-severe-label

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20240621
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