Active Ingredient (In Each 5 Ml)
Cetirizine HCl 5 mg
Members Mark Childrens Cetirizine Solution
FDA Label NDC 68196-475
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Members Mark Childrens Cetirizine (NDC 68196-475). 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 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
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
- find right dose on chart below
- mL = milliliter
adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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)
- do not use if carton is opened, or if printed neckband is broken or missing
- see bottom panel for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions Or Comments?
1-800-809-0469
Package/Label Principal Display Panel
Member’s Mark™
COMPARE TO CHILDREN’S ZYRTEC® ACTIVE INGREDIENT
TWIN PACK – 2 X 8 OZ
ALLERGY
Children’s Cetirizine
HYDROCHLORIDE ORAL SOLUTION 1 mg/mL ANTIHISTAMINE
24 Hour Relief of
SNEEZING; RUNNY NOSE; ITCHY, WATERY EYES; ITCHY THROAT OR NOSE
GRAPE FLAVOR
AGES 2 + YEARS
INDOOR & OUTDOOR ALLERGIES
DYE-FREE
SUGAR-FREE
GLUTEN FREE
ALCOHOL FREE
PARABEN FREE
2 - 8 FL OZ BOTTLES
TOTAL 16 FL OZ (1 PINT) (480 mL)
DOSING CUP INCLUDED
* Please review the disclaimer below.
