Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE ONCOR PHARMACEUTICALS FDA Approved 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:
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Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 5 mL teaspoonful) Purpose Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine
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.
Strengths
5 ml 12.5 mg
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
UPC
0383720502048 0383720502161
UNII
TC2D6JAD40
Packaging

Diphenhydramine (16 oz) Diphenhydramine (4 oz)

Package Descriptions
  • Diphenhydramine (16 oz) Diphenhydramine (4 oz)

Overview

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:

Indications & 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:

Dosage & 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

Warnings & Precautions
Warnings Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin
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

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

Keep Out of Reach of Children

Keep out of reach of children.

Storage & 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.

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.


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