Med SciforuMed Sciforu

Interface in English. Medical references retain their original language; bilingual names and selected translations are provided.

西药 · 美国药品标签原文

COLD AND FLU SEVERE Daytime, Nighttime

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL

COLD AND FLU SEVERE Daytime, Nighttime · Meijer Distribution, 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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

COLD AND FLU SEVERE Daytime, Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl COLD AND FLU SEVERE Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED D&C YELLOW NO. 10 ALUMINUM LAKE MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE 44;503 COLD AND FLU SEVERE Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE 44;473

活性成分 / Active ingredient

Active ingredients (in each caplet) (Daytime Cold & Flu Severe) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each caplet) (Nighttime Cold & Flu Severe) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

用途 / Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves these common cold and flu symptoms: cough sore throat headache nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps clear nasal passages relieves cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) temporarily reduces fever

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. 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, 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. 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 thyroid disease diabetes high blood pressure heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time.

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 thyroid disease diabetes high blood pressure heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

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 (Nighttime only)

使用中 / When using

When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only)

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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time.

用法用量原文 / Dosage and administration

Directions do not take more than directed 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

储存 / Storage and handling

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

辅料 / Inactive ingredients

Inactive ingredients (Daytime only) corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide Inactive ingredients (Nighttime only) corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

questions

Questions or comments? 1-800-426-9391

package label principal display panel

Principal display panel meijer® NDC 79481-5034-8 COMBO PACK 24 CAPLETS TOTAL COMPARE TO TYLENOL® COLD + FLU SEVERE DAY ACTIVE INGREDIENTS* Daytime COLD & FLU SEVERE ACETAMINOPHEN DEXTROMETHORPHAN HBr GUAIFENESIN PHENYLEPHRINE HCl Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant Fever, Headache, Sore Throat, Nasal Congestion, Cough, Mucus, Chest Congestion Actual Size 16 DAYTIME CAPLETS COMPARE TO TYLENOL® COLD + FLU SEVERE NIGHT ACTIVE INGREDIENTS* Nighttime COLD & FLU SEVERE ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HBr PHENYLEPHRINE HCl Pain Reliever/Fever Reducer Antihistamine Cough Suppressant Nasal Decongestant Fever, Headache, Sore Throat, Runny Nose, Cough, Nasal Congestion Actual Size 8 NIGHTTIME CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Do Not Take Daytime and Nighttime Products at the Same Time. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® COLD + FLU SEVERE Day & Night. 50844 ORG092250347308 Meijer 44-503A473C-08 Meijer 44-503A473C-08

package label principal display panel table

<table width="600px"><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>COMPARE TO TYLENOL&#xAE; COLD + FLU SEVERE DAY ACTIVE INGREDIENTS*</paragraph><paragraph><content styleCode="bold">Daytime COLD &amp; FLU SEVERE</content></paragraph><paragraph><content styleCode="bold">ACETAMINOPHEN DEXTROMETHORPHAN HBr GUAIFENESIN PHENYLEPHRINE HCl</content></paragraph><paragraph><content styleCode="bold">Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant</content></paragraph><paragraph>Fever, Headache, Sore Throat, Nasal Congestion, Cough, Mucus, Chest Congestion</paragraph><paragraph>Actual Size</paragraph><paragraph><content styleCode="bold">16</content> DAYTIME CAPLETS</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>COMPARE TO TYLENOL&#xAE; COLD + FLU SEVERE NIGHT ACTIVE INGREDIENTS*</paragraph><paragraph><content styleCode="bold">Nighttime COLD &amp; FLU SEVERE</content></paragraph><paragraph><content styleCode="bold">ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HBr PHENYLEPHRINE HCl</content></paragraph><paragraph><content styleCode="bold">Pain Reliever/Fever Reducer Antihistamine Cough Suppressant Nasal Decongestant</content></paragraph><paragraph>Fever, Headache, Sore Throat, Runny Nose, Cough, Nasal Congestion</paragraph><paragraph>Actual Size</paragraph><paragraph><content styleCode="bold">8</content> NIGHTTIME CAPLETS</paragraph></td></tr></tbody></table>

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20251106
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