CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
American Health Packaging

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Cetrizine HCL Tablet 10 mg

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

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.

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 25°C (68° and 77°F)
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

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

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60687-165(NDC:60505-2633)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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	Score	no score
Shape	RECTANGLE (pillow-shaped)	Size	9mm
Flavor		Imprint Code	10MG;APO
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60687-165-01	100 in 1 BOX, UNIT-DOSE	06/17/2015	04/30/2020
1	NDC:60687-165-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078317	06/17/2015	04/30/2020

Labeler - American Health Packaging (929561009)

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

Revised: 2/2019

Document Id: 8177534e-7394-50b9-e053-2991aa0a52b4

Set id: 0d3eee18-c6d1-49f8-87a0-544d4f119c81

Version: 2

Effective Time: 20190209

American Health Packaging