Diphenhydramine HCl

Manufacturer: A-S Medication Solutions
Effective date: 2024-01-04
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:06:41

Label at a glance#

ProductDiphenhydramine HCl

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter find right dose on chart below take every 4 to 6 hours, or as directed by a doctor Age Dose adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use

Storage and handling

each teaspoonful (5 mL) contains: sodium 4 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each teaspoonful (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
do not take more than 6 doses in 24 hours
mL = milliliter
find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor

Age	Dose
adults and children 12 years and over	2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years	1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years	do not use unless directed by a doctor
children under 2 years	do not use

Other information

STORAGE AND HANDLING SECTION

each teaspoonful (5 mL) contains: sodium 4 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6541

NDC: 50090-6541-0 118 mL in a BOTTLE, PLASTIC