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

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Childrens Cetirizine Hydrochloride Allergy

Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)


Purpose


Childrens Cetirizine Hydrochloride Allergy Uses



  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use


Ask a doctor before use if you have


Ask a doctor or pharmacist before use if you are


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


If pregnant or breast-feeding:

  • If breast-feeding: not recommended
  • If pregnant: ask a health professional before use.

Keep out of reach of children.


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
  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

Childrens Cetirizine Hydrochloride Allergy Other information

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

Inactive ingredients


Questions?


1-866-850-2876

Dosing cup should be washed and left to air dry after each use.

Do not use if the cap safety seal is broken or missing.


AUROHEALTH




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)



Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of
  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs.
& older
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO
Childrens Cetirizine Hydrochloride Allergy

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)



Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of
  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs.
& older
Grape
Syrup
Dosing Cup
Included
4 fl oz (120 mL)
AUROBINDO
Childrens Cetirizine Hydrochloride Allergy

Childrens Cetirizine Hydrochloride Allergy

Cetirizine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65862-422
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 1 mg

Inactive Ingredients

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

Product Characteristics

Color
YELLOW (Colorless to Pale Yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 240 in 1 BOTTLE
3 NDC:65862-422-48 480 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090750 2010-02-02


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