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

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Cetirizine Hydrochloride

Rugby Laboratories Inc
P and L Development of New York Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Cetirizine 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.

Directions

Adults and children 6 years and over take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and over  ask a doctor.
Children under 6 years of age  ask a doctor
Consumers with liver or kidney disease  ask a doctor

Other Information

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

Inactive Ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc, titanium dioxide.

Questions or comments?

Call 1-800-645-2158, 9am-5pm ET. Monday-Friday

Principal Display Panel

Compare to Active Ingredient in ZYRTEC®*

Original Prescription Strength

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

ANTIHISTAMINE

ALLERGY

Indoor and Outdoor Allergies

24 hour relief of:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat or nose

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

*Rugby Laboratories is not affiliated with the owner of the trademark Zyrtec®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Label

Cetirizine Hydrochloride
Rugby Cetirizine 10 mg Allergy Tablet


Cetirizine Hydrochloride

Cetirizine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-4088
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 10 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
POVIDONES
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white) 8 mm IP;46 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 90 in 1 BLISTER PACK
2 14 in 1 BLISTER PACK
3 30 in 1 BLISTER PACK
4 NDC:0536-4088-07 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078780 2012-03-23


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