CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

SPL UNCLASSIFIED SECTION

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

Drug Facts
Active ingredient (in each tablet)

Cetirizine hydrochloride 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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
ASK DOCTOR/PHARMACIST

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

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)
- TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING
Inactive ingredients

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

call 1-800-206-7821

Manufactured for: Northstar Rx LLC

Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 05/2024
HOW SUPPLIED

Product: 50090-6168

NDC: 50090-6168-1 30 TABLET in a BOTTLE

NDC: 50090-6168-3 90 TABLET in a BOTTLE
CETIRIZINE HYDROCHLORIDE

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICA (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PEG-8 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 50090-6168-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2022
2	NDC: 50090-6168-3	90 in 1 BOTTLE; Type 0: Not a Combination Product	08/02/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	08/05/2015

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-6168)

Cetirizine Hydrochloride (Allergy) by