CETIRIZINE HYDROCHLORIDE tablet, film coated

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Apotex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6053
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078317	05/25/2017	04/30/2021

Labeler - Rite Aid Corporation (014578892)

Registrant - Apotex Inc. (209429182)

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