Childrens Allergy Relief Solution
FDA Label NDC 63868-865

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.d.m.a., Inc. for the product Childrens Allergy Relief (NDC 63868-865). 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 teaspoonful), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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 Teaspoonful)

Cetirizine Hydrochloride USP 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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

When Using This Product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery.

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding

  • If breast-feeding: not recommended
  • If pregnant: 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

  • use only with enclosed dosing cup
    • adults and children 6 years and over
    		1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
    adults 65 years and over
    		1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age
    		1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
    children under 2 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor

Other Information

store between 20° to 25° C (68° to 77°F)

Inactive Ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions?

call 248-449-9300

Distributed by:
C.D.M.A, Inc.©
43157 W.Nine Mile
Novi.MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Package Label- Principal Display Panel 4 Fl Oz (120 Ml Bottle)

NDC 63868-865-04

*Compare to the
active ingredient in
Children's ZYRTEC®

Children's

Allergy
Relief

Indoor & Outdoor
Allergies

Cetirizine Hydrochloride
Oral Solution, USP 1mg/mL
Antihistamine

For Relief of:
Runny Nose | Sneezing
Itchy, Watery Eyes |
Itchy Nose or Throat

2 yrs. & older

Grape
Flavor

Dosing Cup
Included

4 FL OZ (120 mL)





Package Label- Principal Display Panel 4 Fl Oz (120 mL Bottle) (Cetirizine Fig1)

Package Label- Principal Display Panel 4 Fl Oz (120 mL Bottle) (Cetirizine Fig1)

* Please review the disclaimer below.