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Package Insert and Label Information: Allergy Relief

By Publix Super Markets Inc | Last revised: 21 January 2009

ALLERGY RELIEF- cetirizine hydrochloride tablet
Publix Super Markets Inc

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

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

adults and children 6 years and over 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

  • do not use if printed foil under cap is broken or missing (Bottle Only)
  • do not use if blister unit is broken or torn (Blister Only)
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Principal Display Panel

INDOOR & OUTDOOR ALLERGIES

allergy relief

CETIRIZINE HYDROCHLORIDE TABLETS, 10mg

ANTIHISTAMINE

24 hour relief of:

sneezing

itchy, watery eyes

runny nose

itchy throat or nose

ACTUAL SIZE

Original Prescription Strength

Compare to Active Ingredient in Zyrtec®

Allergy Relief Carton Image 1
(click image for full-size original)

Allergy Relief Carton Image 1

Allergy Relief Carton Image 2
(click image for full-size original)

Allergy Relief Carton Image 2

ALLERGY RELIEF
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-458
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 4H2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56062-458-66 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 14 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (56062-458-66)
2 NDC:56062-458-39 1 BOTTLE (BOTTLE) in 1 PACKAGE contains a BOTTLE
2 30 TABLET (TABLET) in 1 BOTTLE This package is contained within the PACKAGE (56062-458-39)
3 NDC:56062-458-72 1 BOTTLE (BOTTLE) in 1 PACKAGE contains a BOTTLE
3 60 TABLET (TABLET) in 1 BOTTLE This package is contained within the PACKAGE (56062-458-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078336 01/21/2009
Labeler — Publix Super Markets Inc (006922009)

Revised: 01/2009 Publix Super Markets Inc