Cetirizine HCL 10 mg All Day Allergy Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetirizine HCL 10 mg All Day Allergy Relief

Freds 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 HCL 10 mg All Day Allergy Relief 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 reation to this product occurs. Seek medical help right away.

  • 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.

adults and children 6 years and over Take one 10 mg table 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
  • store between 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

All Day Allergy Relief

Cetirizine HCl, 10 mg Tablets

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Tablets

Compare to the active ingredient in Zyrtec®**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®.

Product of USA

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Cetirizine HCL 10 mg All Day Allergy Relief

Fred's All Day Allergy Relief Tablets
 

Cetirizine HCL 10 mg All Day Allergy Relief

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-129
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
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm IP46 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BLISTER PACK
2 NDC:55315-129-30 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078780 2013-03-01


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Be sure to consult your doctor before taking any medication!
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