Cetirizine hydrochloride tablet

Active ingredient

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

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 useif you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking 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 doctorif 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

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

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions?1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

Spl unclassified section

Distributed by:

Physicians Total Care, Inc.

Tulsa, OK 74146

Spl unclassified section

NDC 54868-5845-0

Cetirizine HCl Tablets, USP

10 mg

antihistamine

Cetirizine hydrochloride label image

Ingredients and appearance - Product information

Cetirizine hydrochloride tablet- Cetirizine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 54868-5845
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidones ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)

Product Characteristics

Color WHITE (white to off-white) Size 8 mm
Shape ROUND (round shape) Score 1
Imprint Code SZ;906

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077946 USA

Labeler - Physicians Total Care, Inc.( 194123980)

Establishment

Name ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel( 54868-5845)

Principal display panel

NDC 0781-1684-64

Cetirizine HCl Tablets, USP

10 mg

antihistamine

30 Tablets.

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Package label.principal display panel