说明与适用边界
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spl product data elements
Cold Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl Nighttime Cold Multi Symptom 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 Daytime Cold Multi Symptom acetaminophen, dextromethorphan hbr, phenylephrine hcl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE 44;470
活性成分 / Active ingredient
Active ingredients (in each caplet) (Daytime Cold Multi-Symptom) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Active ingredients (in each caplet) (Nighttime Cold Multi-Symptom) 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 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 promotes nasal and sinus drainage 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 diabetes thyroid disease heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) high blood pressure persistent or chronic cough such as occurs with smoking, asthma, or emphysema difficulty in urination due to enlargement of the prostate gland 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) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (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 diabetes thyroid disease heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) high blood pressure persistent or chronic cough such as occurs with smoking, asthma, or emphysema difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
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 excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (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 (Nighttime only) 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, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, 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? 1-888-287-1915
package label principal display panel
Principal Display Panel NDC 49035-931-08 equate™ DAYTIME MULTI-SYMPTOM Cold Acetaminophen Dextromethorphan HBr Phenylephrine HCl Pain Reliever/Fever reducer Cough Suppressant Nasal Decongestant Headache, Fever, Sore Throat, Cough, Nasal Congestion Actual Size Pseudoephedrine Free 12 CAPLETS equate™ NIGHTTIME MULTI-SYMPTOM Cold Acetaminophen Chlorpheniramine maleate Dextromethorphan HBr Phenylephrine HCl Pain Reliever/Fever Reducer Antihistamine Cough Suppressant Nasal Decongestant Headache, Fever, Sore Throat, Runny Nose, Cough, Nasal Congestion Actual Size Pseudoephedrine Free 12 CAPLETS Equate 44-470C473 Equate 44-470C473
package label principal display panel table
<table width="433px"><col/><col/><tbody><tr><td><paragraph><content styleCode="bold">equate™<content styleCode="bold"> </content></content></paragraph><paragraph><content styleCode="bold">DAYTIME</content></paragraph><paragraph><content styleCode="bold">MULTI-SYMPTOM</content></paragraph><paragraph><content styleCode="bold">Cold</content></paragraph><paragraph><content styleCode="bold"> Acetaminophen</content> Dextromethorphan HBr Phenylephrine HCl</paragraph><paragraph>Pain Reliever/Fever reducer Cough Suppressant Nasal Decongestant</paragraph><paragraph>Headache, Fever, Sore Throat, Cough, Nasal Congestion</paragraph><paragraph>Actual Size</paragraph><paragraph> Pseudoephedrine Free</paragraph><paragraph><content styleCode="bold"> </content><content styleCode="bold">12 </content><content styleCode="bold">CAPLETS</content> </paragraph></td><td styleCode=" Lrule"><paragraph><content styleCode="bold">equate™ </content></paragraph><paragraph><content styleCode="bold">NIGHTTIME</content></paragraph><paragraph><content styleCode="bold">MULTI-SYMPTOM</content></paragraph><paragraph><content styleCode="bold">Cold</content></paragraph><paragraph><content styleCode="bold">Acetaminophen</content> Chlorpheniramine maleate Dextromethorphan HBr Phenylephrine HCl</paragraph><paragraph>Pain Reliever/Fever Reducer Antihistamine Cough Suppressant Nasal Decongestant</paragraph><paragraph>Headache, Fever, Sore Throat, Runny Nose, Cough, Nasal Congestion</paragraph><paragraph> Actual Size</paragraph><paragraph>Pseudoephedrine Free</paragraph><paragraph><content styleCode="bold">12</content><content styleCode="bold"> CAPLETS </content></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
- 17 / 20260908
- 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.

