说明与适用边界
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spl product data elements
Childrens Benadryl DYE-FREE ALLERGY Diphenhydramine hydrochloride ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Clear, colorless
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg
用途 / Purpose
Purpose Antihistamine
适应证 / Indications and usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
警告 / Warnings
Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
禁用事项 / Do not use
Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin
咨询医生 / Ask a doctor
Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
使用中 / When using
When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
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. (1-800-222-1222)
用法用量原文 / Dosage and administration
Directions find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
dosage and administration table
<table width="70%" styleCode="Noautorules"><col width="50%" align="left" valign="top"/><col width="50%" align="left" valign="top"/><thead><tr styleCode="Toprule Botrule"><th styleCode="Rrule">Age (yr)</th><th>Dose (mL)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Rrule">children under 2 years</td><td>do not use</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">children 2 to 5 years</td><td>do not use unless directed by a doctor</td></tr><tr><td styleCode="Rrule">children 6 to 11 years</td><td>5 mL to 10 mL</td></tr></tbody></table>
储存 / Storage and handling
Other information each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing see bottom panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution
questions
Questions or comments? call 1-877-717-2824 or 215-273-8755 (collect)
package label principal display panel
PRINCIPAL DISPLAY PANEL NDC 50580-535-01 Children's Benadryl ® DYE-FREE ALLERGY Diphenhydramine HCl/antihistamine 12.5 mg/5 mL oral solution 4-6 Hours/Dose RELIEF OF: Runny Nose Sneezing Itchy,Watery Eyes Itchy Throat or Nose ✔ Free Of: Dyes Alcohol Sugar Parabens High Fructose Corn Syrup Bubble Gum! Flavored Liquid 4 fl oz (118 mL) Principal Display Panel
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 10 / 20241127
- 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.

