CETIRIZINE HYDROCHLORIDE tablet, film coated

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Indoco Remedies Limited , INDOCO REMEDIES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Cetirizine HCl 10 mg

PURPOSE

Antihistamine

USE(S)

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

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

• 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 inner seal is broken or missing
• FDA approved dissolution test specifications differ from USP

Inactive ingredients

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

Questions?

Call at +1-855-642-2594

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC: 14445-152-30

Cetirizine Hydrochloride Tablets
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

24 hour Relief of
 runny nose
 sneezing
 itchy, watery eyes
 itchy throat or nose
30 Tablets
10 mg each

Container Label:

 

Carton Label:

    

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14445-152
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	C10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14445-152-30	1 in 1 CARTON	10/04/2024
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 14445-152-90	1 in 1 CARTON	10/04/2024
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 14445-152-01	1 in 1 CARTON	10/04/2024
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 14445-152-03	1 in 1 CARTON	10/04/2024
4		300 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 14445-152-05	1 in 1 CARTON	10/04/2024
5		500 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	ANDA218895	10/04/2024

Labeler - Indoco Remedies Limited (650445950)

Establishment
Name	Address	ID/FEI	Business Operations
INDOCO REMEDIES LIMITED		918608431	ANALYSIS(14445-152) , LABEL(14445-152) , MANUFACTURE(14445-152) , PACK(14445-152)