CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG - cetirizine hydrochloride tablet 
CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG - cetirizine hydrochloride tablet 
MARKSANS PHARMA LIMITED

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Allergy Relief
Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mg

Active ingredient (in each tablet)

For 5 mg:

Cetirizine HCl USP 5 mg


For 10 mg:

Cetirizine HCl USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


Warnings

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding



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

For 5 mg:


adults and children 6 years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of ageask a doctor 
consumers with liver or kidney diseaseask a doctor  

 

For 10 mg:


adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor 

Other information

•store between 20° to 25°C (68° to 77°F)
•do not use if foil seal under cap is broken or missing

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide


Questions?
Call at 1-877-376-4271

PRINCIPAL DISPLAY PANEL

NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count bottle label


cetirizine-hcl-5-mg-30ct-bottle


NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count carton label


cetirizine-hcl-5-mg-30ct-ifc

    
NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count bottle label


cetirizine-hcl-5-mg-100ct-bottle


NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count carton label


cetirizine-hcl-5-mg-100ct-ifc


NDC 25000-219-14 
Cetirizine Hydrochloride Tablets USP, 5 mg
1000s count bottle label  


cetirizine-hcl-5-mg-1000ct-bottle


NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label

10mg-30sbottle

 


NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg

30s count carton label


cetirizine-hcl-10-mg-30s-ifc


NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg
100s count bottle label

10mg-100sbottle

 


NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg

100s count carton label


cetirizine-hcl-10-mg-100ct-ifc


NDC 25000-220-14
Cetirizine Hydrochloride Tablets USP, 10 mg
1000s count bottle label


cetirizine-hcl-10-mg-1000s-label


NDC 25000-220-78
Cetirizine Hydrochloride Tablets USP, 10 mg

7s count carton label


cetirizine-hcl-10-mg-7s-ifc


NDC 25000-220-81
Cetirizine Hydrochloride Tablets USP, 10 mg

14s count carton label


cetirizine-hcl-10-mg-14s-ifc



CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-219
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeRECTANGLE (Rounded-off rectangular shaped) Size7mm
FlavorImprint Code J219
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-219-031 in 1 CARTON01/13/2022
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:25000-219-081 in 1 CARTON01/13/2022
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-219-141000 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07893301/13/2022
CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-220
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeRECTANGLE (Rounded-off rectangular shaped) Size9mm
FlavorImprint Code J220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-220-031 in 1 CARTON01/13/2022
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:25000-220-081 in 1 CARTON01/13/2022
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-220-141000 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2022
4NDC:25000-220-781 in 1 CARTON04/17/2023
47 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:25000-220-811 in 1 CARTON07/21/2023
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07893301/13/2022
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-219, 25000-220)

Revised: 8/2023
Document Id: 27416199-4b9b-48c1-99e9-0766015cf840
Set id: 652b0c65-a3f2-4454-9cf2-51a3389282cc
Version: 10
Effective Time: 20230823
 
MARKSANS PHARMA LIMITED