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西药 · 美国药品标签原文

Mucinex Nightshift Sinus Maximum Strength

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE

Mucinex Nightshift Sinus Maximum Strength · Reckitt Benckiser LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Mucinex Nightshift Sinus Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICA MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW) POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN VVV;LOGOcrescentmoonplus

spl unclassified section

Drug Facts Dist. by: RB Health (US) Parsippany, NJ 07054-0224

活性成分 / Active ingredient

Active ingredients (in each caplet) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Triprolidine HCl 1.25 mg Antihistamine

active ingredient table

<table width="75%"><col width="60%" align="left" valign="top"/><col width="40%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each caplet)</content></th><th><content styleCode="italics">Purposes</content></th></tr></thead><tbody><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 HCl 5 mg</td><td>Nasal decongestant</td></tr><tr><td>Triprolidine HCl 1.25 mg</td><td>Antihistamine</td></tr></tbody></table>

用途 / Purpose

Active ingredients (in each caplet) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Triprolidine HCl 1.25 mg Antihistamine

purpose table

<table width="75%"><col width="60%" align="left" valign="top"/><col width="40%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each caplet)</content></th><th><content styleCode="italics">Purposes</content></th></tr></thead><tbody><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 HCl 5 mg</td><td>Nasal decongestant</td></tr><tr><td>Triprolidine HCl 1.25 mg</td><td>Antihistamine</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 sinus congestion and pressure runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever 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 4,000 mg 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. 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 diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, 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 use caution 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. 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.

咨询医生 / Ask a doctor

Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

咨询医药人员 / Ask a doctor or pharmacist

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

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 use caution 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.

用法用量原文 / Dosage and administration

Directions do not take more than directed (see Overdose warning ) do not take more than 8 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use

储存 / Storage and handling

Other information store at 20-25°C (68-77°F)

辅料 / Inactive ingredients

Inactive ingredients croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

questions

Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

package label principal display panel

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton FAST RELEASE. POWERFUL SYMPTOM RELIEF! NDC 72854-240-20 MAXIMUM STRENGTH Mucinex® NIGHTSHIFT SINUS Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCl – Nasal Decongestant Triprolidine HCl – Antihistamine NIGHTTIME RELIEF FOR A BETTER MORNING ACTUAL SIZE ✓COUGH ✓FEVER ✓SORE THROAT ✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTION 20 CAPLETS FOR AGES 12+ FAST RELEASE PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20260513
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