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

MAXIMUM STRENGTH Sinus Relief

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

MAXIMUM STRENGTH Sinus Relief · Topco Associates LLC。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

MAXIMUM STRENGTH Sinus Relief Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate MAXIMUM STRENGTH Sinus Relief Day Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN 811 MAXIMUM STRENGTH Sinus Relief Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN 812

spl unclassified section

MAXIMUM STRENGTH** Sinus Relief Day Drug Facts MAXIMUM STRENGTH** Sinus Relief Night Drug Facts COMPARE TO MUCINEX ® SINUS-MAX ® DAY ACTIVE INGREDIENTS* COMPARE TO MUCINEX ® SINUS-MAX ® NIGHT ACTIVE INGREDIENTS* DAY TIME FOR AGES 12+ NIGHT TIME FOR AGES 12+ *These products are not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex ® Sinus-Max ® Day & Night Softgel **Per 4-hour dose. Do not take DAY & NIGHT softgels at the same time. Do not take more than a total of 12 softgels in a 24-hour period. Do not take the first dose of the NIGHT softgels sooner than 4 hours after the last dose of the DAY softgels unless directed by a doctor. Take only as directed. READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 Product of United Arab Emirates REV.01-042023 CT7616282412

活性成分 / Active ingredient

Active ingredients (in each softgel) DAY Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) NIGHT Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

用途 / Purpose

Purposes Pain reliever Cough suppressant Expectorant Nasal decongestant Purposes Pain reliever Cough suppressant Antihistamine Nasal decongestant

适应证 / Indications and usage

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing • temporarily promotes nasal and/or sinus drainage

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these 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. Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to 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 these products • 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: In case of overdose, get medical help or contact a Poison Control Center right away. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products 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. Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • 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 • taking sedatives or tranquilizers When using these products • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery 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.

儿童安全 / Keep out of reach of children

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

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 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use

储存 / Storage and handling

Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture

辅料 / Inactive ingredients

Inactive ingredients edible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution Inactive ingredients edible printing ink, FD&C Blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

questions

Questions or comments? Call: 1-888-423-0139 Questions or comments? Call: 1-888-423-0139

package label principal display panel

Packaging Topco-824

来源、版本与许可

资料类型
美国药品标签原文
版本
1 / 20231229
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