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spl product data elements
childrens cold cough brompheniramine maleate, dextromethorphan hydrobromide BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL SOLUTION
活性成分 / Active ingredient
Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg
用途 / Purpose
Purposes Antihistamine Cough suppressant
适应证 / Indications and usage
Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold • temporarily relieves these symptoms due to hay fever (allergic rhinitis): • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
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. • to make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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. • to make a child sleepy
咨询医生 / Ask a doctor
Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic 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 sedatives or tranquilizers
使用中 / When using
When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
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. A persistent cough may be a sign 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 • do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
dosage and administration table
<table styleCode="Noautorules" width="100%"><col width="49%"/><col width="49%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>age</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>dose</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>adults and children 12 years over</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>20 mL every 4 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 6 to under 12 years</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>10 mL every 4 hours</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>children under 6 years</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information • each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
questions
Questions or comments? 1-800-719-9260
package label principal display panel
Package/Label Principal Display Panel meijer ® CHILDREN’S | ages 6 & up cold & cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) COMPARE TO CHILDREN’S DIMETAPP ® COLD & COUGH ACTIVE INGREDIENTS RELIEVES: RUNNY NOSE, ITCHY, WATERY EYES COUGHING, SNEEZING GRAPE FLAVOR Multi-Symptom Alcohol Free Safe and Effective Relief without Phenylephrine 4 FL OZ (118 mL) cold & cough
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20250708
- 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.

