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SIMPLY RIGHT

Sam's West Inc
Taro Pharmaceuticals U.S.A., Inc.

SIMPLY RIGHT children's cetirizine


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

SIMPLY RIGHT Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 (1-800-222-1222).

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 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

SIMPLY RIGHT Other information

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

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

SIMPLY RIGHT

SIMPLY RIGHT

Cetirizine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68196-102
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACETIC ACID
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water
SODIUM ACETATE ANHYDROUS
Sucralose

Product Characteristics

Color
YELLOW (colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:68196-102-02 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090182 2011-09-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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