Diphenhydramine Hydrochloride Solution

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Citric Acid Cherry Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sodium Saccharin Sorbitol Solution Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-27

Medication Information

Description

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:

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 55106-9

Active ingredients (in each 5 mL teaspoonful) Purpose

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

Warnings

Do not use

- to make a child sleepy

- with any other product containing diphenhydramine, even one used on skin

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

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.

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.

Inactive Ingredients

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

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 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.

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.

Structured Label Content

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:

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL teaspoonful) Purpose

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

Warnings

Do not use

- to make a child sleepy

- with any other product containing diphenhydramine, even one used on skin

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

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.

Other Information (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.

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.

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 This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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:", "34088-5": "In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.", "50565-1": "Keep out of reach of children.", "55106-9": "Active ingredients (in each 5 mL teaspoonful) Purpose Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine", "Warnings": "Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin", "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", "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.", "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.", "Inactive ingredients": "citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.", "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 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.", "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."}

Diphenhydramine Hydrochloride Solution

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information