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西药 · 美国药品标签原文

CVS NightTime Cold

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE

CVS NightTime Cold · CVS PHARMACY。此记录对应特定产品,标签收录不代表所有用途获批。

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spl product data elements

CVS NightTime Cold acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE

spl unclassified section

Drug Facts Distributed by:

活性成分 / Active ingredient

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

用途 / Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • 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 4 doses in 24 hours, which is the maximum daily amount for this product • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless • 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. In case of overdose, get medical help or contact a Poison Control Center right away at 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.

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 • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland • a sodium-restricted diet

咨询医药人员 / Ask a doctor or pharmacist

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

使用中 / When using

When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

停用事项 / Stop use

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • 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 • take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

dosage and administration table

<table styleCode="Noautorules" width="100%"><col width="46%"/><col width="46%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults &amp; children 12 yrs &amp; over </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>30 mL every 4 hrs </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 4 to under 12 yrs </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor </paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>children under 4 yrs </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>do not use </paragraph></td></tr></tbody></table>

储存 / Storage and handling

Other information • each 30 mL contains: sodium 81 mg • Store at room temperature. Do not refrigerate.

辅料 / Inactive ingredients

Inactive ingredients citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

questions

Questions? 1-866-467-2748

package label principal display panel

PRINCIPAL DISPLAY PANEL - 354mL Bottle Label *Compare to the active ingredients in VICKS ® NyQuil™ Severe + Vapo COOL™ NDC 51316-641-12 NightTime Cold & Flu Relief Acetaminophen- Pain reliever/Fever reducer Dextromethorphan HBr – Cough suppressant Doxylamine Succinate - Antihistamine Phenylephrine HCl – Nasal decongestant For Relief of • Minor Aches & Pains, Fever • Nasal Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough 12 FL OZ (354 ml) *This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®NyQuil™ Severe+ VapoCOOL™ CVS NightTime Cold & Flu Cold Relief

来源、版本与许可

资料类型
美国药品标签原文
版本
7 / 20260814
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