CHILDRENS ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE FRED'S, INC. FDA Approved 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA090750
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Cetirizine Hydrochloride USP 5 mg
Inactive Ingredients
Inactive ingredients banana flavor glacial acetic acid glycerin grape flavor methylparaben propylene glycol propylparaben purified water sodium acetate sucrose
Strengths
5 ml 5 mg
Quantities
120 ml
Treats Conditions
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
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0084579127580
UNII
64O047KTOA
Packaging

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)

Package Descriptions
  • 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)

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Antihistamine

When Using

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 & Ask a Doctor

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of 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).

Storage & Handling

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

Questions

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!


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