CETIRIZINE HCL capsule

Active ingredient (in each capsule)

Cetirizine HCl 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
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.

Directions

adults and children 6 years and over	one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20º-25ºC (68º-77ºF)
- avoid high humidity and excessive heat above 40ºC (104ºF)
- protect from light
Inactive ingredients

gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
Questions or comments?

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)
SPL UNCLASSIFIED SECTION

*ZYRTEC® IS A REGISTERED TRADEMARK OF KENVUE INC.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

PROUDLY DISTRIBUTED
BY THE KROGER CO.
CINCINNATI, OHIO 45202
‡OUR PHARMACIST RECOMMENDED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

L0001257

R0326

Lot No.:
Exp. Date:
Principal Display Panel-25s count

NDC: 59450-020-86

Kroger®

health

COMPARE TO THE ACTIVE

INGREDIENT IN ZYRTEC ®ⱡ

Dye Free

Allergy Relief

Cetitizine HCl Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

UP TO

24HR

RELIEF

24 HOUR RELIEF OF:
SNEEZING, RUNNY NOSE
ITCHY, WATERY EYES
ITCHY THROAT OR NOSE

25 SOFTGELS†
†LIQUID-FILLED CAPSULES

*Liquid-filled capsules

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL
cetirizine hcl capsule

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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59450-020-86	1 in 1 CARTON	05/25/2026
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 59450-020-15	1 in 1 CARTON	05/25/2026
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022429	05/25/2026

Labeler - KROGER COMPANY (006999528)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(59450-020)

Do not use