说明与适用边界
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spl product data elements
Maximum Strength Nighttime Cold and Flu Acetaminophen , Diphenhydramine HCl,Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant
active ingredient table
<table width="75%"><col width="37%"/><col width="38%"/><thead><tr><th align="left" styleCode="Toprule " valign="top"><content styleCode="bold"><content styleCode="italics">Active ingredients (in each 20 mL)</content></content></th><th align="left" styleCode="Toprule " valign="top"><content styleCode="bold"><content styleCode="italics">Purposes</content></content></th></tr><tr><th align="left" colspan="2" styleCode="Botrule " valign="top"/></tr></thead><tbody><tr><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">Acetaminophen 650 mg</content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">Pain reliever/fever reducer</content></paragraph></td></tr><tr><td valign="top"><paragraph>Diphenhydramine HCl 25 mg</paragraph></td><td valign="top"><paragraph>Antihistamine/cough suppressant</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Phenylephrine HCl 10 mg</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Nasal decongestant</paragraph></td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant
purpose table
<table width="75%"><col width="37%"/><col width="38%"/><thead><tr><th align="left" styleCode="Toprule " valign="top"><content styleCode="bold"><content styleCode="italics">Active ingredients (in each 20 mL)</content></content></th><th align="left" styleCode="Toprule " valign="top"><content styleCode="bold"><content styleCode="italics">Purposes</content></content></th></tr><tr><th align="left" colspan="2" styleCode="Botrule " valign="top"/></tr></thead><tbody><tr><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">Acetaminophen 650 mg</content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">Pain reliever/fever reducer</content></paragraph></td></tr><tr><td valign="top"><paragraph>Diphenhydramine HCl 25 mg</paragraph></td><td valign="top"><paragraph>Antihistamine/cough suppressant</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Phenylephrine HCl 10 mg</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Nasal decongestant</paragraph></td></tr></tbody></table>
适应证 / Indications and usage
Uses • temporarily relieves these common cold and flu symptoms: • cough • nasal congestion • minor aches and pains • sore throat • headache • runny nose • sneezing • temporarily reduces fever • controls cough to help you get to sleep
警告 / Warnings
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 doses in 24 hours, which is the maximum daily amount • 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, 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. • with any other drug containing diphenhydramine, even one used on the skin • 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 an enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if • you are taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. 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. • with any other drug containing diphenhydramine, even one used on the skin • 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 • trouble urinating due to an enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
咨询医药人员 / Ask a doctor or pharmacist
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 • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
停用事项 / Stop use
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
过量 / Overdosage
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. 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 • do not take more than directed (see Overdose warning) • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL= milliliter • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours • children under 12 years of age: do not use
储存 / Storage and handling
Other information • each 20 mL contains: sodium 6 mg • low sodium • store at room temperature • do not refrigerate • dosing cup provided
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
questions
Questions or comments? 1-888-287-1915
package label principal display panel
PRINCIPAL DISPLAY PANEL - NDC# 30142-736-06 Compare to Mucinex ® Fast-Max ® Maximum Strength Might Time Cold & Flu Active Ingredients Maximum Strength Night Time Cold & Flu Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Phenylephrine HCl Nasal Decongestant Relieves: • Sore Throat; Itchy Throat-Cough • Nasal Congestion – Sneezing & Runny Nose • Headache – Body Pain For Ages 12+ 6 FL OZ (180 mL) *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ® Fast- Max ® Maximum Strength Nighttime Cold & Flu Tamper evident: do not use if printed seal under cap is broken or missing. ‡Maximum Strength per 4 hour dose. Distributed by: Maximum Strength Nighttime Cold & Flu
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20260902
- 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.

