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Allergy Relief

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Cetirizine HCl 10 mg

Purpose

Antihistamine

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 doctor if you have

  • liver or kidney disease. Your doctor should determine if you need a different dose.

Ask doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when drivinga motor vehicle or operating machinery

Stop use and ask 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 accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

  •  Adults and children 6 years and older One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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 Ask a doctor
disease

Allergy Relief Other information

  • store between 20°C to 25°C (68°F to 77°F )
  • do not use if safety seal under cap is open or missing

Inactive Ingredients

hypromellose*, lactose monohydrate, magnesium stearate, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl glycol*, povidone*, starch, talc* and titanium dioxide. *May also contain.

Questions or comments

Call toll free 1-888-952-0050

Manufactured for

A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788

Package/Label Principal Display Panel

Allergy relief

Cetirizine 10 mg/ Antihistamine

Indoor & Outdoor Allergies

24 hour Relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Allergy Relief

Cetirizine HCl 10 mg TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-350(NDC:60505-2633)
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
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONES
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 9 mm 10MG;APO RECTANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:62211-350-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078317 2013-12-10


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Be sure to consult your doctor before taking any medication!
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