Drug Facts

Active ingredient

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 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 pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a octor or Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 6 years and over: 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 disease: ask a doctor

Other information

store between 20°C to 25°C (68°F to 77°F)
do not use if blister unit is broken or torn
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or Comments

Call toll free 1-877-994-3666
Monday to Friday, 8 am to 6 pm

Package/Label Principal Display Panel

Cetirizine 10mg Front

Cetirizine 10mg back

ALLERGY RELIEF
cetirizine hcl 10 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50066-396
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	2 pieces
Shape	RECTANGLE (pillow-shaped)	Size	9mm
Flavor		Imprint Code	G;4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50066-396-82	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2020	12/31/2022
2	NDC:50066-396-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2020	12/31/2022
3	NDC:50066-396-45	3 in 1 CARTON	09/20/2019	10/26/2022
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:50066-396-09	1 in 1 CARTON	09/20/2019	10/26/2022
4		10 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	ANDA209274	12/22/2017	12/31/2022

Labeler - Genomma Labs USA, Inc (832323534)

Revised: 9/2019

Document Id: 41d565e6-2429-4b69-9d60-fd65b9071dd1

Set id: 9f266258-7a76-49eb-810c-93389023d57e

Version: 8

Effective Time: 20190920

Genomma Labs USA, Inc