CETIRIZINE HCL- cetirizine tablet 
CETIRIZINE HCL- cetirizine 
GLENMARK THERAPEUTICS INC., USA

----------

Drug Facts

Cetirizine HCl 5 mg

Cetirizine HCl 10 mg

Antihistamine

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

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)

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

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

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

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5mg365label

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NDC 72657-130-89

5 mg - 150 Tablets
(contains one bottle of 60 Tablets
and one bottle of 90 Tablets

5mgkit

Principal Display Panel

10mgkit
CETIRIZINE HCL 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-128-301 in 1 CARTON05/13/2024
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72657-128-451 in 1 CARTON05/13/2024
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:72657-128-601 in 1 CARTON05/13/2024
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:72657-128-701 in 1 CARTON05/13/2024
470 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:72657-128-901 in 1 CARTON05/13/2024
590 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:72657-128-081 in 1 CARTON05/13/2024
6120 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:72657-128-141 in 1 CARTON05/13/2024
7140 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:72657-128-151 in 1 CARTON05/13/2024
8150 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:72657-128-181 in 1 CARTON05/13/2024
9180 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:72657-128-241 in 1 CARTON05/13/2024
10240 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:72657-128-031 in 1 CARTON05/13/2024
11300 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:72657-128-351 in 1 CARTON05/13/2024
12365 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:72657-128-041 in 1 CARTON05/13/2024
13400 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:72657-128-812 in 1 CARTON05/13/2024
1460 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:72657-128-822 in 1 CARTON05/13/2024
1570 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:72657-128-842 in 1 CARTON05/13/2024
1690 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:72657-128-862 in 1 CARTON05/13/2024
17120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
CETIRIZINE HCL 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code C;17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-129-301 in 1 CARTON05/13/2024
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72657-129-451 in 1 CARTON05/13/2024
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:72657-129-601 in 1 CARTON05/13/2024
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:72657-129-701 in 1 CARTON05/13/2024
470 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:72657-129-901 in 1 CARTON05/13/2024
590 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:72657-129-081 in 1 CARTON05/13/2024
6120 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:72657-129-141 in 1 CARTON05/13/2024
7140 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:72657-129-151 in 1 CARTON05/13/2024
8150 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:72657-129-181 in 1 CARTON05/13/2024
9180 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:72657-129-241 in 1 CARTON05/13/2024
10240 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:72657-129-031 in 1 CARTON05/13/2024
11300 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:72657-129-351 in 1 CARTON05/13/2024
12365 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:72657-129-041 in 1 CARTON05/13/2024
13400 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:72657-129-812 in 1 CARTON05/13/2024
1460 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:72657-129-822 in 1 CARTON05/13/2024
1570 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:72657-129-842 in 1 CARTON05/13/2024
1690 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:72657-129-862 in 1 CARTON05/13/2024
17120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
CETIRIZINE HCL 
cetirizine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-130
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-130-051 in 1 PACKAGE; Type 0: Not a Combination Product05/13/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 60 
Part 21 BOTTLE 90 
Part 1 of 2
CETIRIZINE HCL 
cetirizine tablet
Product Information
Item Code (Source)NDC:72657-128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
Part 2 of 2
CETIRIZINE HCL 
cetirizine tablet
Product Information
Item Code (Source)NDC:72657-128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
190 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
CETIRIZINE HCL 
cetirizine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-131
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-131-891 in 1 PACKAGE; Type 0: Not a Combination Product05/13/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 60 
Part 21 BOTTLE 90 
Part 1 of 2
CETIRIZINE HCL 
cetirizine tablet
Product Information
Item Code (Source)NDC:72657-129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code C;17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
Part 2 of 2
CETIRIZINE HCL 
cetirizine tablet
Product Information
Item Code (Source)NDC:72657-129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code C;17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
190 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842705/13/2024
Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
Establishment
NameAddressID/FEIBusiness Operations
Glenmark Pharmaceuticals Limited862603186ANALYSIS(72657-128, 72657-129, 72657-130, 72657-131) , MANUFACTURE(72657-128, 72657-129, 72657-130, 72657-131)

Revised: 6/2024
Document Id: 6b94aa16-24b0-42d5-9910-aac62d132e8a
Set id: 04b08c52-5390-4cdb-a9e7-fca81fffdc73
Version: 3
Effective Time: 20240617
 
GLENMARK THERAPEUTICS INC., USA