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

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SIMPLY RIGHT
children's cetirizine

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

adults and children 6 years and over5 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 over5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

Questions?

Call 1-866-923-4914

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton

Twin Pack – 2 X 8 FL OZ

Compare to Children's Zyrtec® active ingredient*

NDC 68196-102-07

Member's Mark

24 hour relief

original prescription strength

children's
cetirizine

hydrochloride oral solution
1 mg/mL antihistamine
allergy

24 hour relief of:

• Sneezing; runny nose; itchy,
watery eyes; itchy throat or nose
• Indoor & outdoor allergies
• Sugar free • Dye free
2 years and older

Grape flavor
Dosing cup included

Contains 2 bottles of 8 FL OZ (240 mL)
each/total 16 FL OZ (480mL)

PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton
SIMPLY RIGHT   CHILDRENS CETIRIZINE
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-102
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 anhydrous (UNII: NVG71ZZ7P0)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-102-022 in 1 CARTON09/08/2011
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68196-102-012 in 1 CARTON09/08/2011
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68196-102-072 in 1 CARTON09/08/2011
3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018209/08/2011
Labeler - Sam's West Inc (051957769)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(68196-102)

Revised: 7/2021
Document Id: 351aad60-18d7-4c75-bb72-5e05538da592
Set id: 48b47541-cf0c-48a7-9a65-2158fd1284f1
Version: 4
Effective Time: 20210720
 
Sam's West Inc