Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Active ingredient (in each 10 mL)

Diphenhydramine HCl USP 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

• in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

Ask a doctor before use if you have

• glaucoma • a breathing problem such as emphysema or chronic bronchitis
• a sodium restricted diet • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives

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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

• Use the following dosage guidelines when using this product

Age (yr)	Dose (mL)
Adults and children 12 years and older	take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours.
Children 6 years to under 12 years	take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours
Children under 6 years	ask a doctor

Other information

• each 5mL contains sodium 10mg
• each 10mL contains sodium 20mg
• alcohol free, cherry flavor
• store at 20-25°C (68-77°F)
• protect from excessive moisture
• do not use if lid seal is open or damaged
• see top of cup for lot number and expiration date

Inactive ingredients

Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate,
and sucrose.

How Supplied

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:

NDC 69339-151-05 (1) unit dose cup                         5mL
NDC 69339-151-17             40 (4x10) unit dose cups            5mL
NDC 69339-151-19             100 (10x10) unit dose cups 5mL

Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:

NDC 69339-152-01             (1) unit dose cup                         10mL
NDC 69339-152-17             40 (4x10) unit dose cups            10mL
NDC 69339-152-19             100 (10x10) unit dose cups        10mL

Questions or comments?

Call 201-786-6500

Dash Pharmaceuticals LLC
Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117894] Rev 08/20

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 69339-151-05

Diphenydramine HCl Oral Solution, USP

12.5 mg/5 mL

For Institutional Use Only

3 69339 15105 1

Lot # 000000

Exp: MM/YYY

See Insert

DASH Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

Principal Display Panel

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 69339-152-01