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spl product data elements
Sanatos Multi Symptom Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID WATER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID GLYCERIN SUCROSE ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL SODIUM BENZOATE SACCHARIN SODIUM SACCHARIN
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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 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant
active ingredient table
<table border="0" width="100%"><tbody><tr><td><paragraph><content styleCode="italics"><content styleCode="bold">Active ingredients </content></content></paragraph><paragraph><content styleCode="italics">(in each 15 mL, 1 tablespoon)</content></paragraph></td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td><content styleCode="bold">Acetaminophen 325 mg </content></td><td><content styleCode="bold">Pain reliever/fever reducer </content></td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Cough suppressant</td></tr><tr><td>Phenylephrine HCI 5 mg</td><td>Nasal decongestant</td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant
purpose table
<table border="0" width="100%"><tbody><tr><td><paragraph><content styleCode="italics"><content styleCode="bold">Active ingredients </content></content></paragraph><paragraph><content styleCode="italics">(in each 15 mL, 1 tablespoon)</content></paragraph></td><td><content styleCode="italics"><content styleCode="bold">Purposes</content></content></td></tr><tr><td><content styleCode="bold">Acetaminophen 325 mg </content></td><td><content styleCode="bold">Pain reliever/fever reducer </content></td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Cough suppressant</td></tr><tr><td>Phenylephrine HCI 5 mg</td><td>Nasal decongestant</td></tr></tbody></table>
适应证 / Indications and usage
Uses temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adults take more than 4,000 mg if acetaminophen in 24 hours child take more than 5 doses in 24 hours 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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks Stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 this and all drugs 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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
咨询医生 / Ask a doctor
使用中 / When using
When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks
停用事项 / Stop use
Stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 this and all drugs out of reach of children.
过量 / Overdosage
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 a dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 b TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure correct dosing.
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 & children 12 years & over</td><td>30 mL (2 TBSP) every 4 hours</td></tr><tr><td>children 6 years to under 12 years</td><td>15 mL (1 b TBSP) every 4 hours</td></tr><tr><td>children 4 years to under 6 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 information sodium content per tablespoon: 10 mg store at room temperature TAMPER EVIDENT: Do not use if imprinted band is missing or broken.
辅料 / Inactive ingredients
Inactive ingredients citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose
questions
Questions? call 1-866-359-3478
package label principal display panel
Principal Display Panel PDPAPTASantaos Day
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20231117
- 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.

