Diphenhydramine Hcl Oral Solution
FDA Label NDC 69339-152

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natco Pharma Usa Llc for the product Diphenhydramine Hcl Oral Solution (NDC 69339-152). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), active ingredient (in each 10 ml), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

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

Otc - Ask Doctor/Pharmacist

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

Otc - Keep Out Of Reach Of 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 yearsask 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

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