Childrens Allergy
FDA Label NDC 17856-0361

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 Childrens Allergy (NDC 17856-0361). 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 drug facts, purpose, uses, warnings, ask a doctor before use if the child has, ask a doctor or pharmacist before use if you, 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

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use If The Child Has

→ Ask A Doctor Or Pharmacist Before Use If You

→ When Using This Product

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label-principal Display Panel

Drug Facts

Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 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

Warnings

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

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

Ask A Doctor Or Pharmacist Before Use If You

are taking sedatives or tranquilizers

When Using This Product

sedatives and tranquilizers may increase drowsiness
marked drowsiness may occur
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

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
children under 6 years of age	ask a doctor
children 6 years to under 12 years of age	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 9 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
see bottom panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

Package Label-Principal Display Panel

NDC 17856-0361-01

Compare to
Children's Benadryl^®
active ingredient*

Children's
ALLERGY
Antihistamine
diphenhydramine hydrochloride
25mg/10 mL oral solution
liquid medication

Relieves: