CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG- cetirizine hydrochloride tablet CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG- cetirizine hydrochloride tablet

Cetirizine Hydrochloride Tablets, 10 mg by

Drug Labeling and Warnings

Cetirizine Hydrochloride Tablets, 10 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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 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 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)

Directions

For 5 mg:

• adults and children 6 years and over: 1 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 over: 1 tablet (5 mg) once daily; 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

 

For 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° 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

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

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

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

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

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

30s count bottle label

 

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

30s count carton label

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

 

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

100s count carton label

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

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

7s count carton label

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

14s count carton label

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-219
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
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
Color	WHITE (white to off white)	Score	no score
Shape	RECTANGLE (Rounded-off rectangular shaped)	Size	7mm
Flavor		Imprint Code	J219
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-219-03	1 in 1 CARTON	01/13/2022
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-219-08	1 in 1 CARTON	01/13/2022
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-219-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078933	01/13/2022

CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-220
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
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
Color	WHITE (white to off white)	Score	no score
Shape	RECTANGLE (Rounded-off rectangular shaped)	Size	9mm
Flavor		Imprint Code	J220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-220-03	1 in 1 CARTON	01/13/2022
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-220-08	1 in 1 CARTON	01/13/2022
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-220-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2022
4	NDC: 25000-220-78	1 in 1 CARTON	04/17/2023
4		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 25000-220-81	1 in 1 CARTON	07/21/2023
5		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078933	01/13/2022

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-219, 25000-220)