Active Ingredient (In Each 5 Ml Teaspoonful)
Cetirizine Hydrochloride USP 5 mg
Childrens Allergy Relief Solution
FDA Label NDC 55315-354
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fred's, Inc. for the product Childrens Allergy Relief (NDC 55315-354). 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
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 (1-800-222-1222).
Directions
- use only with enclosed dosing cup
- mL=milliliter
| 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 1-855-274-4122
Distributed by:
Fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com
| fred’s Promise Not Happy With This Product? Just Bring It Back For a Refund! |
Package Label- Principal Display Panel 4 Fl Oz (120 Ml Bottle)
NDC 55315-354-31
fred*s
KIDS®
2 yrs & older
Children's
Allergy
Relief
Indoor & Outdoor
Allergies
Cetirizine Hydrochloride
Oral Solution, USP 1mg/mL
Antihistamine
Grape Flavored Syrup
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Dosing Cup
Included
4 FL OZ (120 mL)
Compare to
*Children's ZYRTEC®
Package Label- Principal Display Panel 4 Fl Oz (120 mL Bottle) (Cetirizine Fig1)
* Please review the disclaimer below.
