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西药 · 美国药品标签原文

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX · Aurohealth 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

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spl product data elements

DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE POLISTIREX ANHYDROUS CITRIC ACID EDETATE DISODIUM ETHYLCELLULOSE AQUEOUS DISPERSION TYPE B FD&C YELLOW NO. 6 HIGH FRUCTOSE CORN SYRUP ASCORBIC ACID METHYLPARABEN POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 PROPYLENE GLYCOL WATER SUCROSE TRAGACANTH XANTHAN GUM

spl unclassified section

Drug Facts Other information each 5 mL contains: sodium 5 mg store at 20º to 25°C (68º to 77°F) dosing cup provided

活性成分 / Active ingredient

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

用途 / Purpose

Purpose Cough suppressant

适应证 / Indications and usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

警告 / Warnings

Warnings Do not use 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 chronic cough that lasts such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

停用事项 / Stop use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, 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 (1-800-222-1222) right away.

用法用量原文 / Dosage and administration

Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

dosage and administration table

<table cellspacing="0" cellpadding="0" border="0" width="489.839"><colgroup><col width="48.1129513983166%"/><col width="51.8870486016834%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">adults and children 12 years of age and over </td><td styleCode="Rrule" valign="top">10 mL every 12 hours, not to exceed 20 mL in 24 hours </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">children 6 to under 12 years of age </td><td styleCode="Rrule" valign="top">5 mL every 12 hours, not to exceed 10 mL in 24 hours </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">children 4 to under 6 years of age </td><td styleCode="Rrule" valign="top">2.5 mL every 12 hours, not to exceed 5 mL in 24 hours </td></tr><tr><td styleCode="Lrule Rrule" valign="top">children under 4 years of age </td><td styleCode="Rrule" valign="top">do not use </td></tr></tbody></table>

辅料 / Inactive ingredients

Inactive ingredients citric acid anhydrous, edetate disodium, ethylcellulose, FD & C Yellow no. 6, high fructose corn syrup, masker citrus flavour, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sucrose, tragacanth, xanthan gum

questions

Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India

package label principal display panel

PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label AUROHEALTH NDC 58602-617-05 COUGH SUPPRESSANT Dextromethorphan Polistirex Extended-Release Oral Suspension 30 mg/5 mL COUGH 12 HOUR RELIEF CONTAINS NO FEVER REDUCER OR PAIN RELIEVER DAY or NIGHT ALCOHOL FREE Orange Flavored Liquid 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label NDC 58602-617-05 Compare to Delsym ® active ingredient * AUROHEALTH COUGH SUPPRESSANT Dextromethorphan Polistirex Extended- Release Oral Suspension 30 mg/5 mL COUGH DAY or NIGHT Alcohol Free 12 HOUR RELIEF Orange Flavored Liquid 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20260513
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