Label: CETIRIZINE HCL- cetirizine tablet
CETIRIZINE HCL- cetirizine kit
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NDC Code(s):
72657-128-03,
72657-128-04,
72657-128-08,
72657-128-14, view more72657-128-15, 72657-128-18, 72657-128-24, 72657-128-30, 72657-128-35, 72657-128-45, 72657-128-60, 72657-128-70, 72657-128-81, 72657-128-82, 72657-128-84, 72657-128-86, 72657-128-90, 72657-129-03, 72657-129-04, 72657-129-08, 72657-129-14, 72657-129-15, 72657-129-18, 72657-129-24, 72657-129-30, 72657-129-35, 72657-129-45, 72657-129-60, 72657-129-70, 72657-129-81, 72657-129-82, 72657-129-84, 72657-129-86, 72657-129-90, 72657-130-05, 72657-131-89
- Packager: GLENMARK THERAPEUTICS INC., USA
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 17, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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- 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
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- if pregnant: ask a health professional before use.
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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
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
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INGREDIENTS AND APPEARANCE
CETIRIZINE HCL
cetirizine tabletProduct 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 tabletProduct 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 kitProduct 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 tabletProduct 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 tabletProduct 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 kitProduct 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 tabletProduct 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 tabletProduct 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)