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

†This product is not manufactured or distributed by the owners of Zyrtec®

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

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO BMAA0326
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Scan here for more
information or
call 1-888-423-0139

QUALITY GUARANTEED
This TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed.

L0001273

R0326
Principal Display Panel-40's count

NDC: 36800-543-15

TopCare

health

COMPARE TO THE ACTIVE

INGREDIENT IN ZYRTEC®†

All-Day

Allergy

CETIRIZINE HCI CAPSULES, 10 mg
ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

RELIEF OF:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

40
SOFTGELS**

**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: 36800-543-15	1 in 1 CARTON	05/30/2026
1		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 36800-543-86	1 in 1 CARTON	05/30/2026
2		25 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	05/30/2026

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(36800-543)

Do not use