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西药 · 美国药品标签原文

basic care nighttime severe cold and flu

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

basic care nighttime severe cold and flu · Amazon.com Services LLC。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

basic care nighttime severe cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C GREEN NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM

活性成分 / Active ingredient

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg

用途 / Purpose

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 and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and 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 • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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. • to make a child sleepy • 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 • glaucoma • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers 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 5 days (children) or 7 days (adults) • 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. • to make a child sleepy • 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 • glaucoma • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

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 5 days (children) or 7 days (adults) • 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. 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.

用法用量原文 / Dosage and administration

Directions • take only as directed – see Overdose warning • 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 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

dosage and administration table

<table styleCode="Noautorules" width="100%"><col width="45%"/><col width="45%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>adults &amp; children 12 yrs &amp; over</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>30 mL every 4 hrs</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>children 6 to under 12 yrs</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>15 mL every 4 hrs</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>children 4 to under 6 yrs</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>ask a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>children under 4 yrs</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>do not use</item></list></td></tr></tbody></table>

其他安全资料 / Other safety information

Other information • each 15 mL contains: sodium 15 mg • store at 20-25°C (68-77°F)

辅料 / Inactive ingredients

Inactive ingredients anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

questions

Questions? 1-800-719-9260

package label principal display panel

Package/Label Principal Display Panel amazon basic care Multi-Symptom Relief Compare to Vicks ® NyQuil ® Severe Honey Flavor active ingredients Nighttime Severe Cold & Flu Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Doxylamine Succinate Pain Reliever, Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine Max Strength Honey Flavor 12 FL OZ (355 mL) nighttime severe cold and flu image

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20241111
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