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spl product data elements
Sanatos Multi Symptoms Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID FD&C GREEN NO. 3 FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID SUCRALOSE SODIUM BENZOATE SODIUM CITRATE SORBITOL SOLUTION DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER D&C YELLOW NO. 10 GLYCERIN PROPYLENE GLYCOL XANTHAN GUM Medicinal
spl unclassified section
Drug Facts
Distributed by: Pharmadel New Castle, DE 19720 www.pharmadel.com Facebook/PHARMADELUSA
活性成分 / Active ingredient
Active ingredients & Purposes Active ingredients (in each 30 mL) 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><paragraph><content styleCode="italics"><content styleCode="bold">Active ingredients</content></content></paragraph><paragraph>(in each 30 mL)</paragraph></td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td>Acetaminophen 650 mg</td><td>Pain reliever/ fever reducer</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) 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><paragraph><content styleCode="italics"><content styleCode="bold">Active ingredients</content></content></paragraph><paragraph>(in each 30 mL)</paragraph></td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td>Acetaminophen 650 mg</td><td>Pain reliever/ fever reducer</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 common cold/flu symptoms associated with minor aches and pains headache sore throat runny nose cough due to minor throat and bronchial irritation sneezing temoprarily reduces fever
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: adults take more than 4 doses in 24 hours, which is the maxium daily amount child takes more than 3 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product 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 user has a sodium-restricted diet has liver disease has glaucoma has cough that occurs with too much phlegm (mucus) has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema has trouble urinating due to enlarged prostate gland is a child with pain of arthritis Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain 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 any 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 right away. Prompt 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.
咨询医生 / Ask a doctor
Ask a doctor before use if user has a sodium-restricted diet has liver disease has glaucoma has cough that occurs with too much phlegm (mucus) has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema has trouble urinating due to enlarged prostate gland is a child with pain of arthritis
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
停用事项 / Stop use
Stop use and ask a doctor if pain 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 any 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. Prompt 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 use only dosing cup provided shake well before use if you are taking other cold/flu products, read complete labeling adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours children under 12 years ask a doctor
dosage and administration table
<table border="0" width="100%"><tbody><tr><td>adults & children 12 years & over</td><td>30 mL every 4 hours, do not exceed <content styleCode="bold">(child) 3 doses</content> and <content styleCode="bold"> (adult) 4 doses </content>in 24 hours </td></tr><tr><td>children under 12 years</td><td><content styleCode="bold">ask a doctor</content></td></tr></tbody></table>
其他安全资料 / Other safety information
Other informaiton each 30 mL contains: sodium 10 mg store between 68-77°F (20-25°C)
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? +1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
package label principal display panel
Princpal Display Panel PDP Sanatos MS 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.

