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西药 · 美国药品标签原文

Cold plus Flu Congestion Severe

ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

Cold plus Flu Congestion Severe · CHAIN DRUG MARKETING ASSOCIATION, INC.。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

Cold plus Flu Congestion Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1119

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 for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to 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. Sore throat warning If sore throat is severe, perists 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. 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

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

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 swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

dosage and administration table

<table width="50%" styleCode="Noautorules"><col width="25%" align="left" valign="top"/><col width="75%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td styleCode="Toprule Rrule">adults and children 12 years and over</td><td styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 2 caplets every 4 hours</item><item>swallow whole &#x2013; do not crush, chew, or dissolve</item><item>do not take more than 10 caplets in 24 hours</item></list></td></tr><tr><td styleCode="Rrule">children under 12 years</td><td><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 acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

package label principal display panel

PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-114-24 †Compare to Active Ingredients in TYLENOL® Cold + Head Congestion Severe For Adults Cold + Head Congestion Severe Acetaminophen, Phenylephrine HCl, Guaifenesin Pain Reliever | Fever Reducer, Nasal Decongestant, Expectorant For Relief of: Headache + Body Aches Fever + Sore Throat Nasal Congestion Mucus + Chest Congestion Actual Size 24 COOL TASTE 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.
核对原始来源