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spl product data elements
Mucus Relief Cold and Flu All in One ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1165
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
active ingredient table
<table width="65%"><col width="60%" valign="top" align="left"/><col width="40%" valign="top" align="right"/><thead><tr styleCode="First Last"><th align="left"><content styleCode="italics">Active ingredients (in each caplet)</content></th><th align="right"><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td align="left">Acetaminophen 325 mg</td><td align="right">Pain reliever/fever reducer</td></tr><tr><td align="left">Dextromethorphan HBr 10 mg</td><td align="right">Cough suppressant</td></tr><tr><td align="left">Guaifenesin 200 mg</td><td align="right">Expectorant</td></tr><tr><td align="left">Phenylephrine HCl 5 mg</td><td align="right">Nasal decongestant</td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
purpose table
<table width="65%"><col width="60%" valign="top" align="left"/><col width="40%" valign="top" align="right"/><thead><tr styleCode="First Last"><th align="left"><content styleCode="italics">Active ingredients (in each caplet)</content></th><th align="right"><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td align="left">Acetaminophen 325 mg</td><td align="right">Pain reliever/fever reducer</td></tr><tr><td align="left">Dextromethorphan HBr 10 mg</td><td align="right">Cough suppressant</td></tr><tr><td align="left">Guaifenesin 200 mg</td><td align="right">Expectorant</td></tr><tr><td align="left">Phenylephrine HCl 5 mg</td><td align="right">Nasal decongestant</td></tr></tbody></table>
适应证 / Indications and usage
Uses temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
警告 / Warnings
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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 trouble urinating due to an enlarged prostate gland 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 When using this product do not use more than directed 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 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. 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 trouble urinating due to an enlarged prostate gland 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
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 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.
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 12 caplets in any 24-hour period adults and children 12 years of age and older: take 2 caplets every 4 hours children under 12 years of age: do not use
储存 / Storage and handling
Other information store between 20-25°C (68-77°F) in a dry place
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
package label principal display panel
PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-105-20 †Compare to Active Ingredients in MUCINEX® FAST-MAX® Cold & Flu All-in-One Mucus Relief Cold & Flu All-in-One Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Pain Reliever | Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant For Relief of: Headache, Body Pain, Sore Throat & Fever Cough & Chest Congestion Nasal Congestion Sinus Congestion & Sinus Pressure For Ages 12+ Actual Size 20 CAPLETS image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240807
- 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.

