Otc - Active Ingredient
Active ingredients (in each 5 mL teaspoonful) Purpose
Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine
Diphenhydramine Hydrochloride Solution
FDA Label NDC 83720-502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncor Pharmaceuticals for the product Diphenhydramine Hydrochloride (NDC 83720-502). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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:
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 You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 |
Inactive Ingredients
citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
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.
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 fl OZ. (473 ml)
NDC 83720-502-08
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. 8 fl OZ. (237 ml)
Manufactured In USA For :
Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.
Rev. 02/25
* Please review the disclaimer below.
