Childrens Allergy Liquid
FDA Label NDC 21130-025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Childrens Allergy (NDC 21130-025). 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 the 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 The Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

→ Product 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:
- 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

glaucoma
a breathing problem such as chronic bronchitis
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
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Keep Out Of The Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than 6 doses in 24 hours
take every 4 to 6 hours, or as directed by a doctor
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
keep dosing cup with product
find the right dose on the chart below

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

Other Information

each 5 mL contain: sodium 6 mg
store between 20-25°C (68-77°F). Do not refrigerate.
protect from light. Store in outer carton until contents are used

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40 flavor glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose