Diphenhydramine Hcl Solution
FDA Label NDC 0904-7559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Diphenhydramine Hcl (NDC 0904-7559). 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 active ingredient (in each 5 ml), purpose, uses, do no use, ask a doctor before use if the child has, when using this product, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Do No Use

→ Ask A Doctor Before Use If The Child Has

→ When Using This Product

→ Keep Out Of Reach Of Children.

→ Directions:

→ Other Information

→ Inactive Ingredients:

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

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

Do No Use

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

Ask A Doctor Before Use If The Child Has

a breathing problem such as chronic bronchitis
glaucoma

When Using This Product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
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:

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

Age (yr)	Dose (mL)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 mL to 10 mL

Other Information

each 5 mL contains: sodium 10 mg
store between 20° to 25°C (68° to 77°F).

Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:

NDC 0904-7560-41: 5 mL unit dose cup, in a tray of 10 cups.
NDC 0904-7559-66: 10 mL unit dose cup, in a tray of 10 cups.

Inactive Ingredients:

citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.