Diphenhydramine Hcl Solution
FDA Label NDC 0121-0865

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Diphenhydramine Hcl (NDC 0121-0865). 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), purpose, uses, do not use, ask a doctor before use if the child has, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If The Child Has

→ Otc - Ask Doctor/pharmacist

→ When Using This Product

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Other

Drug Facts

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 Not 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When Using This Product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
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

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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

each 5 mL contains: sodium 10 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

Inactive Ingredients

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