CETIRIZINE HCL- cetirizine tablet CETIRIZINE HCL- cetirizine kit

Cetirizine HCl by

Drug Labeling and Warnings

Cetirizine HCl by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, Glenmark Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetirizine HCl 5 mg

Cetirizine HCl 10 mg

PURPOSE

Antihistamine

INDICATIONS & USAGE

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 an antihistamine containing hydroxyzine

Ask a doctor before useif 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 (1-800-222-1222)

DOSAGE & ADMINISTRATION

Cetirizine Hydrochloride Tablets, USP 5 mg

• adults and children 6 years and over:

  1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours.

• adults 65 years and over:

  1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.

• children under 6 years of age:

  ask a doctor

• consumers with liver or kidney disease:

  ask a doctor

Cetirizine Hydrochloride Tablets, USP 10 mg

• 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°C to 25°C (68°F to 77°F)
• do not use of imprinted foil inner seal on bottle is broken or missing.
• FDA approved organic impurities test procedure differs from USP

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Product of India

February 2024

Package/Label Principal Display Panel

Container label

NDC: 72657-129-35

10 mg - 365 Tablets

Package/Label Principal Display Panel

NDC: 72657-128-35

5 mg- 365 Tablets

Principal Display Panel

Carton label

NDC: 72657-129-35

10 mg - 365 Tablets

Principal Display Panel

NDC: 72657-128-35

5 mg - 365 Tablets

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL 
cetirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-128
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-128-30	1 in 1 CARTON	05/13/2024
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72657-128-45	1 in 1 CARTON	05/13/2024
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 72657-128-60	1 in 1 CARTON	05/13/2024
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 72657-128-70	1 in 1 CARTON	05/13/2024
4		70 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 72657-128-90	1 in 1 CARTON	05/13/2024
5		90 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 72657-128-08	1 in 1 CARTON	05/13/2024
6		120 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 72657-128-14	1 in 1 CARTON	05/13/2024
7		140 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 72657-128-15	1 in 1 CARTON	05/13/2024
8		150 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 72657-128-18	1 in 1 CARTON	05/13/2024
9		180 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 72657-128-24	1 in 1 CARTON	05/13/2024
10		240 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 72657-128-03	1 in 1 CARTON	05/13/2024
11		300 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 72657-128-35	1 in 1 CARTON	05/13/2024
12		365 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 72657-128-04	1 in 1 CARTON	05/13/2024
13		400 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 72657-128-81	2 in 1 CARTON	05/13/2024
14		60 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 72657-128-82	2 in 1 CARTON	05/13/2024
15		70 in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 72657-128-84	2 in 1 CARTON	05/13/2024
16		90 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 72657-128-86	2 in 1 CARTON	05/13/2024
17		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	ANDA078427	05/13/2024

CETIRIZINE HCL 
cetirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-129
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	C;17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-129-30	1 in 1 CARTON	05/13/2024
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72657-129-45	1 in 1 CARTON	05/13/2024
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 72657-129-60	1 in 1 CARTON	05/13/2024
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 72657-129-70	1 in 1 CARTON	05/13/2024
4		70 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 72657-129-90	1 in 1 CARTON	05/13/2024
5		90 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 72657-129-08	1 in 1 CARTON	05/13/2024
6		120 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 72657-129-14	1 in 1 CARTON	05/13/2024
7		140 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 72657-129-15	1 in 1 CARTON	05/13/2024
8		150 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 72657-129-18	1 in 1 CARTON	05/13/2024
9		180 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 72657-129-24	1 in 1 CARTON	05/13/2024
10		240 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 72657-129-03	1 in 1 CARTON	05/13/2024
11		300 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 72657-129-35	1 in 1 CARTON	05/13/2024
12		365 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 72657-129-04	1 in 1 CARTON	05/13/2024
13		400 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 72657-129-81	2 in 1 CARTON	05/13/2024
14		60 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 72657-129-82	2 in 1 CARTON	05/13/2024
15		70 in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 72657-129-84	2 in 1 CARTON	05/13/2024
16		90 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 72657-129-86	2 in 1 CARTON	05/13/2024
17		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	ANDA078427	05/13/2024

CETIRIZINE HCL 
cetirizine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-130

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-130-05	1 in 1 PACKAGE; Type 0: Not a Combination Product	05/13/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	60
Part 2	1 BOTTLE	90

Part 1 of 2

CETIRIZINE HCL 
cetirizine tablet

Product Information
Item Code (Source)	NDC: 72657-128
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		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	ANDA078427	05/13/2024

Part 2 of 2

CETIRIZINE HCL 
cetirizine tablet

Product Information
Item Code (Source)	NDC: 72657-128
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		90 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	ANDA078427	05/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078427	05/13/2024

CETIRIZINE HCL 
cetirizine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-131

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-131-89	1 in 1 PACKAGE; Type 0: Not a Combination Product	05/13/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	60
Part 2	1 BOTTLE	90

Part 1 of 2

CETIRIZINE HCL 
cetirizine tablet

Product Information
Item Code (Source)	NDC: 72657-129
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	C;17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		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	ANDA078427	05/13/2024

Part 2 of 2

CETIRIZINE HCL 
cetirizine tablet

Product Information
Item Code (Source)	NDC: 72657-129
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	C;17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		90 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	ANDA078427	05/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078427	05/13/2024

Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)

Establishment
Name	Address	ID/FEI	Business Operations
Glenmark Pharmaceuticals Limited		862603186	ANALYSIS(72657-128, 72657-129, 72657-130, 72657-131) , MANUFACTURE(72657-128, 72657-129, 72657-130, 72657-131)