说明与适用边界
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spl product data elements
Dextromethorphan HBr 15 mg Dextromethorphan HBr FD&C RED NO. 40 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE WATER PROPYLENE GLYCOL SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CLEAR OVAL PC6
活性成分 / Active ingredient
Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg
用途 / Purpose
Purpose Cough suppressant
适应证 / Indications and usage
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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. Ask a doctor before use if the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.
禁用事项 / Do not use
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 the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
停用事项 / Stop use
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.
用法用量原文 / Dosage and administration
Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years of age and over take 2 capsules every 6 to 8 hours, as needed children under 12 years of age do not use
dosage and administration table
<table border="1"><tbody><tr><td><paragraph>adults and children 12 years of age and over</paragraph></td><td><paragraph> take 2 capsules every 6 to 8 hours, as needed</paragraph></td></tr><tr><td><paragraph>children under 12 years of age</paragraph></td><td><paragraph> do not use</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light
辅料 / Inactive ingredients
Inactive ingredients FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
questions
Questions or comments? Call toll free 1-855-215-8180
package label principal display panel
PRINCIPAL DISPLAY PANEL - Shipping Label Dextromethorphan HBr Capsules, 15 mg Quantity : 12000 Capsules NDC No. : 53345-011-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20241121
- 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.

