ShopRite Childrens Allergy description, usages, side effects, indications, overdosage, supplying and lots more!

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ShopRite Childrens Allergy

Wakefern Food Corporation

ShopRite Children’s Allergy Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

ShopRite Childrens Allergy 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. (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 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

ShopRite Childrens Allergy 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-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Children’s Zyrtec®

Children’s

2 YRS & OLDER

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY

Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

Dosing Cup Included

Grape flavor

4 FL OZ (118 mL)

ShopRite Childrens Allergy

cetirizine hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41190-974
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
SUCROSE

Product Characteristics

Color
YELLOW (Pale Yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:41190-974-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090254 2013-07-02


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