Diphenhydramine
FDA Label NDC 76413-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Diphenhydramine (NDC 76413-333). 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 not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, keep out of reach of children., 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 Not Use

→ Ask A Doctor Before Use If The Child Has

→ Ask A Doctor Or Pharmacist Before Use If The Child Is

→ When Using This Product

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 118 Ml Bottle Label

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:
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes

Do Not Use

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

Ask A Doctor Before Use If The Child Has

a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedatives or tranquilizers

When Using This Product

marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

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 15 mg
store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
do not use if printed neckband is broken or missing

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution