CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
Rite Aid Corporation

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Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 10

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

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

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 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

store between 20° and 25°C (68° - 77°F)
do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering
meets USP Dissolution Test 3

Inactive ingredients

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

Questions or comments?

Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Principal Display Panel

Rite Aid NDC 11822-7053-8

Original Prescription Strength

allergy relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 count Bottle

Principal Display Panel

Rite Aid NDC 11822-6053-9

Original Prescription Strength

allergy relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

60 count Carton

Principal Display Panel

Rite Aid NDC 11822-6059-7

Original Prescription Strength

allergy relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

120 count Carton

ceti-lbl-10mg-120ctn-riteaid

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-6053
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

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:11822-6053-7	2 in 1 CARTON	05/25/2017	04/30/2021
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11822-6053-9	1 in 1 CARTON	05/25/2017	04/30/2021
2		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078317	05/25/2017	04/30/2021

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-7053
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

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:11822-7053-8	1 in 1 CARTON	05/25/2017	04/30/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078317	05/25/2017	04/30/2021

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-6059
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

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:11822-6059-7	1 in 1 CARTON	05/25/2017	04/30/2021
1		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078317	05/25/2017	04/30/2021

Labeler - Rite Aid Corporation (014578892)

Registrant - Apotex Inc. (209429182)

Name	Address	ID/FEI	Business Operations
Establishment
Apotex Inc.		209429182	analysis(11822-6053, 11822-7053, 11822-6059) , manufacture(11822-6053, 11822-7053, 11822-6059)

Revised: 6/2019

Document Id: e5d9bf97-798c-a5ea-b3a1-31da1225905c

Set id: 0fc08cfa-3f71-58d9-5689-6630a2bb40e1

Version: 3

Effective Time: 20190612

Rite Aid Corporation