CETIRIZINE HYDROLORIDE Allergy description, usages, side effects, indications, overdosage, supplying and lots more!

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CETIRIZINE HYDROLORIDE Allergy

CARACO PHARMACEUTICAL LABORATORIES, LTD
Sun Pharmaceutical Industries Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active Ingredient (in each 5 mL teaspoonful)

Cetirizine hydrochloride, USP 5mg

Purpose

Antihistamine


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

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
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 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                              

CETIRIZINE HYDROLORIDE Allergy Other information

Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

Inactive ingredients


Questions or comments?


1-800-818-4555

Dosing Cup Included

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

Do not use if carton is opened, or if seal on bottle is broken or missing.

Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

              Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

              Bryan, Ohio 43506


Principal Display Panel


NDC 57664-263-31

2 years & older

Children’s

Cetirizine

Hydrochloride

1mg / mL  Oral Solution, USP

antihistamine

ALLERGY

Indoor and Outdoor Allergies

24 Hour Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Dosing Cup Included

Do not use if carton is opened, or if seal on bottle is broken or missing.

2 years and older

Grape Syrup




CETIRIZINE HYDROLORIDE Allergy

CETIRIZINE HYDROLORIDE Allergy

CETIRIZINE HYDROLORIDE SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57664-263
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
water
propylene glycol
PROPYLPARABEN
SODIUM ACETATE
SUCROSE

Product Characteristics

Color
YELLOW (Colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57664-263-31 120 in 1 BOTTLE
2 NDC:57664-263-34 470 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091327 2011-12-01


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