Cetrizine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetrizine Hydrochloride

Major Pharmaceuticals
Bio-Pharm, Inc.

Cetrizine Hydrochloride Oral Solution 1mg/mL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5mL teaspoonful)

Cetirizine HCl 5mg

Purpose

Antihistamine

Cetrizine Hydrochloride 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 tsp (teaspoonful) (5mL) or 2 tsp (teaspoonfuls) (10mL) once daily depending upon severity of symptoms; do not take more than 2tsp (teaspoonfuls) (10mL) in 24 hours
adults 65 years and over 1 tsp (teaspoonful) (5mL) once daily; do not take more than 1 tsp (teaspoonful) (5mL) in 24 hours
children 2 to under 6 years of age ½ tsp (teaspoonful) (2.5mL) once daily. If needed, dose can be increased to a maximum of 1 tsp (teaspoonful) (5mL) once daily or ½ tsp(teaspoonful) (2.5mL) every 12 hours. Do not give more than 1 tsp (teaspoonful) (5mL) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Cetrizine Hydrochloride Other information

  • store between 20° to 25°C (68° to 77°F)
  • Do not use if foil seal over mouth of the bottle is torn, broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-800-616-2471

Distributed by
MAJOR® PHARMACEUTICALS

31778 Enterprise Drive
Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

MAJOR®
NDC 0904-6372-20

COMPARE TO the active ingredient
of CHILDREN'S ZYRTEC®*

Children's
ALL DAY
Allergy

Cetirizine Hydrochloride
Oral Solution 1 mg/mL
Antihistamine

INDOOR & OUTDOOR
ALLERGIES

24 HOUR RELIEF OF:
Runny Nose / Itchy, Watery Eyes
Itchy Throat or Nose / Sneezing

4 FL OZ
(118 mL)

24 Hour
2 yrs. & older
Dosing Cup Included

Dye-Free

Grape
Flavored
Syrup

Cetrizine Hydrochloride

Cetrizine Hydrochloride

CETIRIZINE HYDROCHLORIDE SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-6372
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
METHYLPARABEN
PROPYLPARABEN
GLYCERIN
propylene glycol
SODIUM ACETATE
GRAPE
ACETIC ACID
SUCROSE
water

Product Characteristics

Color
YELLOW (Colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0904-6372-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090474 2014-02-24


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Be sure to consult your doctor before taking any medication!
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