DIPHENHYDRAMINE HYDROCHLORIDE solution

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Oncor Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5 mL teaspoonful)                  Purpose

Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83720-502
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
CHERRY (UNII: BUC5I9595W)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83720-502-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025
2	NDC: 83720-502-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2025

Labeler - Oncor Pharmaceuticals (119032580)

Registrant - Oncor Pharmaceuticals (119032580)