Cetirizine hydrochloride tablet, film coated

Spl unclassified section

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 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

Otc - do not use section

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Otc - ask doctor section

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

Otc - ask doctor/pharmacist section

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

Otc - stop use section

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Warnings section

If pregnant or breast-feeding

  • if breast-feeding; not recommended
  • if pregnant; ask a health professional before use

Otc - keep out of reach of children section

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 and 25C (68 and 77F)
  • FOR YOUR PROTECTION: Do not use product if blister is torn or broken
  • USP Dissolution Test 3

Inactive ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions or comments?

about the drug call Apotex Corporation at 1-800-706-5575, weekdays, 8:30am 5:00pm Eastern Standard Time; about the packaging call American Health Packaging at 1-800-707-4621

Ingredients and appearance - Product information

Cetirizine hydrochloride tablet, film coated- Cetirizine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 60687-165
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
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Magnesium stearate ( UNII: 70097M6I30)
Hypromelloses ( UNII: 3NXW29V3WO)
Polydextrose ( UNII: VH2XOU12IE)
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color white Size 9 mm
Shape RECTANGLE (pillow-shaped) Score 1
Imprint Code 10MG;APO

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078317 USA

Labeler - American Health Packaging( 929561009)

Establishment

Name ID/FEI Business Operations
American Health Packaging 929561009 repack( 60687-165)

Principal display panel

NDC 60687-165-01

Cetirizine
Cetirizine Hyrdrochloride Tablets, USP
Antihistamine
Indoor and Outdoor Allergies

10 mg
24 Hour

100 Tablets (10 x 10)

The drug product contained in this
package is from NDC # 60505-2633,
Apotex Corp.

Packaged and Distributed by:
American Health Packaging,
2550 John Glenn Avenue, Suite A,
Columbus, OH 43217

716501
Rev. 05/2015