说明与适用边界
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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.

