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西药 · 美国药品标签原文

Sanatos Nighttime Multi Symptoms

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE

Sanatos Nighttime Multi Symptoms · Pharmadel 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

Sanatos Nighttime Multi Symptoms Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID FD&C GREEN NO. 3 D&C YELLOW NO. 10 SACCHARIN SODIUM SACCHARIN SODIUM BENZOATE SODIUM CITRATE PROPYLENE GLYCOL SUCROSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN

spl unclassified section

Drug Facts Distributed by: Pharmadel LLC Seaford, DE 19973 www.sanatos.com

活性成分 / Active ingredient

Active Ingredients & Purposes Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine

active ingredient table

<table border="0" width="100%"><tbody><tr><td><content styleCode="italics"><content styleCode="bold">Active ingredients</content></content> (in each 30 mL dose cup) </td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td><content styleCode="bold">Acetaminophen 650 mg.....</content></td><td><content styleCode="bold">Pain reliever/ fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 30 mg.....</td><td>Cough suppressant</td></tr><tr><td>Doxylamine succinate 12.5 mg.....</td><td>Antihistamine</td></tr></tbody></table>

用途 / Purpose

Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine

purpose table

<table border="0" width="100%"><tbody><tr><td><content styleCode="italics"><content styleCode="bold">Active ingredients</content></content> (in each 30 mL dose cup) </td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td><content styleCode="bold">Acetaminophen 650 mg.....</content></td><td><content styleCode="bold">Pain reliever/ fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 30 mg.....</td><td>Cough suppressant</td></tr><tr><td>Doxylamine succinate 12.5 mg.....</td><td>Antihistamine</td></tr></tbody></table>

适应证 / Indications and usage

Uses temporarily relieves these common cold/flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. Severe 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 everyday 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. to make a child sleepy 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 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 tranquilizers taking the blood thinning drug warfarin 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 Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by fever fever gets worse or lasts more than 3 days cough lasts more than 7 days, comes back, or occurs with fever, 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center 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. 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 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 tranquilizers taking the blood thinning drug warfarin

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 fever fever gets worse or lasts more than 3 days cough lasts more than 7 days, comes back, or occurs with 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.

user safety warnings

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center 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 recommended - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours age dose adults & children 12 years & over 30 mL(2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.

dosage and administration table

<table border="0" width="100%"><tbody><tr><td><content styleCode="bold">age</content></td><td><content styleCode="bold">dose</content></td></tr><tr><td>adults &amp; children 12 years &amp; over </td><td>30 mL(2TBSP) 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 informaiton each 30 mL dose cup contains: sodium 45 mg store at room temperature Tamper Evident: Do not use if imprinted shrink band is missing or broken.

辅料 / Inactive ingredients

Inactive ingredients citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

questions

Questions? call 1-866-359-3478

package label principal display panel

Princpal Display Panel PDPAPTASanatos Night

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20231122
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