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西药 · 美国药品标签原文

苯海拉明 · Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE

Diphenhydramine Hydrochloride · Oncor Pharmaceuticals。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CITRIC ACID CHERRY FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SODIUM SACCHARIN SORBITOL SOLUTION SUCRALOSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE

活性成分 / Active ingredient

Active ingredients (in each 5 mL teaspoonful) Purpose Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine

适应证 / Indications and usage

Uses - sneezing - runny nose - itchy, watery eyes - itching of the nose or throat - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

警告 / Warnings

Warnings 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 you have - 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 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

妊娠 / Pregnancy

If pregnant or breast-feeding, ask a health professional before use.

用法用量原文 / Dosage and administration

Directions - take every 4 to 6 hours or as directed by a doctor - do not take more then directed - mL=milliliter - find right dose on chart below Children under 2 years Do not use Children 2 to 5 years Ask a doctor Children 6 to 11 years 1-2 teaspoonful Adults and children 12 years and over 2-4 teaspoonful

dosage and administration table

<table width="100%"> <caption/> <tbody> <tr> <td> Children under 2 years</td> <td> Do not use</td> </tr> <tr> <td> Children 2 to 5 years</td> <td> Ask a doctor</td> </tr> <tr> <td> Children 6 to 11 years</td> <td> 1-2 teaspoonful</td> </tr> <tr> <td> Adults and children 12 years and over</td> <td> 2-4 teaspoonful</td> </tr> </tbody> </table>

辅料 / Inactive ingredients

Inactive ingredients citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

储存 / Storage and handling

Other information - each 1 tsp (5mL) contains: sodium 4 mg - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing. - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

儿童安全 / Keep out of reach of children

Keep out of reach of children.

过量 / Overdosage

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

questions

Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

spl unclassified section

用途 / Purpose

Principal Display Panel Oncor Pharmaceuticals NDC 83720-502-16 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT. 16 OZ. (473 ml) NDC 83720-502-04 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT. 4 OZ. (118 ml) Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 03/25

package label principal display panel

Diphenhydramine (16 oz) Diphenhydramine (4 oz)

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20250327
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.
核对原始来源