Diphenhydramine Hcl
FDA Label NDC 17856-6985

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Diphenhydramine Hcl (NDC 17856-6985). 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 teaspoonful (5 ml)), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Teaspoonful (5 Ml))

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Teaspoonful (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 You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
marked drowsiness may occur
use caution when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Age	Dose
adults and children 12 years and over	2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years	1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years	do not use unless directed by a doctor
children under 2 years	do not use

Other Information

each teaspoonful (5 mL) contains: sodium 5 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose