SIMPLY RIGHT CHILDRENS CETIRIZINE- cetirizine hydrochloride liquid 
Sam's West Inc

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Sam’s West, Inc. Children’s Cetirizine Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 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

do not use if carton is opened, or if printed neckband is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions or comments?

1-800-809-0469

Principal Display Panel

TWIN PACK

24 hour relief

Original prescription strength

children’s cetirizine

hydrochloride oral solution 1 mg/mL

antihistamine

Compare to Children’s Zyrtec® active ingredient

allergy

24 hour relief of:

sneezing; runny nose; itchy, watery eyes; itchy throat or nose

indoor & outdoor allergies

2 yrs. & older

grape syrup

4 FL OZ (120 mL)

Dosing cup included

Simply Right Children's Cetirizine Image 1
Simply Right Children's Cetirizine Image 2
SIMPLY RIGHT CHILDRENS CETIRIZINE 
cetirizine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-974
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (Pale Yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-974-261 in 1 CARTON01/26/201208/03/2014
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09025401/26/201208/03/2014
Labeler - Sam's West Inc (051957769)

Revised: 11/2017
 
Sam's West Inc