Cetirizine HCl by TOP CARE (Topco Associates LLC) / Bionpharma Inc. / Patheon Softgels Inc. CETIRIZINE HCL capsule

Cetirizine HCl by

Drug Labeling and Warnings

Cetirizine HCl by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC), Bionpharma Inc., Patheon Softgels Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

call toll free 1-888-423-0139 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

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

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

QUALITY GUARANTEED

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

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO BMAA0824
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

L0000898

R0924

Principal Display Panel

NDC: 36800-542-86

TopCare®

health
COMPARE TO THE ACTIVE
INGREDIENT IN ZYRTEC®*

All-Day

Allergy

CETIRIZINE HCI CAPSULES, 10mg
ANTIHISTAMINE

Indoor & outdoor allergies
24-hour

RELIEF OF:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

actual size

25

SOFTGELS**

**LIQUID-FILLED CAPSULES

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL 
cetirizine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-542
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	CE1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-542-86	1 in 1 PACKAGE	11/22/2024
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 36800-542-15	1 in 1 PACKAGE	11/22/2024
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022429	11/22/2024

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

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Softgels Inc.		002193829	manufacture(36800-542)