Diphenydramine Hcl Oral Solution, Usp

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Water Sucrose Sodium Benzoate Sodium Citrate, Unspecified Form D&c Red No. 33 Fd&c Red No. 40 Poloxamer 407 Sodium Chloride

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-14

Medication Information

Purpose

Antihistamine

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

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

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

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

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

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

Active Ingredient

Diphenhydramine HCl USP 12.5 mg

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.

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

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

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

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

Purpose

Antihistamine

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

Do Not Use (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

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

Other Information (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

Active Ingredient (Active ingredient )

Diphenhydramine HCl USP 12.5 mg

Inactive Ingredients (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.

Questions Or Comments? (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 (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

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

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat", "42229-5": "Drug Facts", "50565-1": "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)", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives", "Purpose": "Antihistamine", "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", "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", "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", "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", "Active ingredient ": "Diphenhydramine HCl USP 12.5 mg", "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.", "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", "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", "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"}

Diphenydramine Hcl Oral Solution, Usp

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information