说明与适用边界
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spl product data elements
Childrens Dibromm Cold and Allergy Brompheniramine maleate, Phenylephrine HCl BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE ANHYDROUS CITRIC ACID
活性成分 / Active ingredient
Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Phenylephrine HCI 5 mg
用途 / Purpose
Purposes Antihistamine Nasal decongestant
适应证 / Indications and usage
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis) runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily restores freer breathing through the nose
警告 / Warnings
Warnings Do not use to sedate a child or to make a child sleepy 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 heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed drowsiness may occur 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 nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever 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 (1-800-222-1222) right away.
禁用事项 / Do not use
Do not use to sedate a child or to make a child sleepy 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 heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers
使用中 / When using
When using this product do not use more than directed drowsiness may occur 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
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 do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use
dosage and administration table
<table><col width="1px"/><col width="1px"/><tbody><tr><td align="center" styleCode=" Botrule Toprule Rrule"> age</td><td align="center" styleCode=" Botrule Toprule"> dose</td></tr><tr><td align="center" styleCode=" Botrule Rrule">adults and children 12 years and over</td><td align="center" styleCode=" Botrule">20 mL every 4 hours</td></tr><tr><td align="center" styleCode=" Botrule Rrule"> children 6 to 11 years</td><td align="center" styleCode=" Botrule"> 10 mL every 4 hours</td></tr><tr><td align="center" styleCode=" Botrule Rrule"> children under 6 years</td><td align="center" styleCode=" Botrule">do not use</td></tr></tbody></table>
储存 / Storage and handling
Other information each 10 mL contains : sodium 6 mg store between 20-25°C (68-77°F). Do not refrigerate.
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
package label principal display panel
Principal Display Panel COMPARE TO CHILDREN'S DIMETAPP® COLD & ALLERGY active ingredients* Children Cold & Allergy Brompheniramine Maleate,2 mg Phenylephrine HCl, 5 mg Antihistamine Nasal Decongestant Grape Flavor Alcohol-Free For Ages 6 Years & Over Relieves Itchy, Watery Eyes Runny Nose Sneezing Stuffy Nose Itching of the Nose or Throat FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com
Package Label LEADER Children's Cold & Allergy Grape Flavor LEADER Children's Cold & Allergy Grape Flavor Brompheniramine maleate 2 mg, Phenylephrine HCl 5 mg Brompheniramine Maleate 2 mg, Phenylephrine HCl 5 mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20240223
- 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.

