说明与适用边界
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spl product data elements
Head Congestion Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, PREGELATINIZED CORN STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1173
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
active ingredient table
<table width="596"><col width="70%" valign="top" align="left"/><col width="30%" 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">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 Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
purpose table
<table width="596"><col width="70%" valign="top" align="left"/><col width="30%" 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">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 symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever
警告 / Warnings
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 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 exceed recommended dosage 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 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. if you have ever had an allergic reaction to this product or any of its ingredients
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 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 exceed recommended dosage
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.
用法用量原文 / Dosage and administration
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
dosage and administration table
<table width="50%"><col width="25%" valign="top" align="left"/><col width="75%" valign="top" align="left"/><tbody><tr styleCode="Botrule"><td align="left" styleCode="Rrule Toprule">adults and children 12 years and over</td><td align="left" styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 2 caplets every 4 hours</item><item>do not take more than 10 caplets in 24 hours</item></list></td></tr><tr><td align="left" styleCode="Rrule">children under 12 years</td><td align="left"><list listType="unordered" styleCode="Square"><item>ask a doctor</item></list></td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, 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 63868-103-24 †Compare to Active Ingredients in SUDAFED PE® Head Congestion + Mucus Head Congestion + Mucus PE Acetaminophen, Guaifenesin, Phenylephrine HCl Pain Reliever | Fever Reducer, Expectorant, Nasal Decongestant For Relief of: Sinus Pressure Headache Chest Congestion Non-Drowsy Actual Size 24 CAPLETS image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20241202
- 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.

