说明与适用边界
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spl product data elements
Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE half pink and half clear with white powder inside CPC;835 Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CPC;836 Banophen Diphenhydramine HCl D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE half pink and half clear with white powder inside CPC;835
活性成分 / Active ingredient
Active Ingredient (in each banded capsule) Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg
用途 / Purpose
Purpose Antihistamine
适应证 / Indications and usage
Use 25 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itchy throat and nose Temporarily relieves these symptoms due to the common cold: runny nose sneezing 50 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold sneezing runny nose itchy, watery eyes itchy throat and nose
警告 / Warnings
WARNINGS Do not use 25 MG to make a child sleepy with any other product containing diphenhydramine, even one used on skin 50 MG to make a child sleepy with any other product containing diphenhydramine, including one applied topically
咨询医生 / Ask a doctor
Ask a doctor before use if you have 25 MG a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland 50 MG glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland
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 marked drowsiness may occur avoid alcoholic drinks 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 right away.
用法用量原文 / Dosage and administration
Directions Take every 4-6 hours Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
dosage and administration table
<table frame="void" width="623"><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">adults and children 12 years of age and over</td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">1 to 2 capsules</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">children 6 years to under 12 years of age</td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">1 capsule</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">children under 6 years of age</td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">do not use this product in children under 6 years of age</td></tr></tbody></table>
<table frame="void" width="623"><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">adults and children 12 years of age and over</td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">1 capsule</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">children 6 years to under 12 years of age</td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top">Ask a doctor, the proper dosage strength is not available in this package**</td></tr></tbody></table>
spl unclassified section
Other Information Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] Protect from moisture Contains lactose
Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152
辅料 / Inactive ingredients
Inactive Ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.
questions
Questions? Questions or comments? (800) 616-2471
package label principal display panel
Major-24BB 24BB-label
Major Label
Major Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 17 / 20260220
- 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.

