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 teaspoonful)

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 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 older 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 ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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

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 - 120 mL Bottle Carton

TWIN PACK

NDC 68196-102-02
24 hour relief

SIMPLY RIGHT
Health Care

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 flavor

4 FL OZ (120 mL)
Dosing cup included

Principal Display Panel - 120 mL Bottle Carton
SIMPLY RIGHT   CHILDRENS CETIRIZINE
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color YELLOW (colorless to slightly yellow) Score     
Shape Size
Flavor GRAPE (sugar free) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68196-102-02 2 in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090182 09/08/2011
Labeler - Sam's West Inc (051957769)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(68196-102)

Revised: 1/2013
Document Id: 6b3ea903-4521-4a60-9d5c-fac8a63ae68c
Set id: 48b47541-cf0c-48a7-9a65-2158fd1284f1
Version: 1
Effective Time: 20130111
 
Sam's West Inc