DailyMed - CETIRIZINE HCL capsule

NDC Code(s): 36800-542-15, 36800-542-86
Packager: TOP CARE (Topco Associates LLC)

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated November 22, 2024

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Active ingredient (in each capsule)
Cetirizine HCl 10 mg

Cetirizine HCl 10 mg
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Purpose
Antihistamine

Antihistamine
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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
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
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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 ...
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.

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Directions

adults and children 6 years and overone 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 ...

Other information
store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light
- store at 20º-25ºC (68º-77ºF)
- avoid high humidity and excessive heat above 40ºC (104ºF)
- protect from light
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Inactive ingredients
FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
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Questions or comments?
call toll free - 1-888-423-0139 (Mon - Fri 9AM - 5PM EST)

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

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

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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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

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	RxCUI	RxNorm NAME	RxTTY
1	1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN
2	1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD
3	1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY

Label: CETIRIZINE HCL capsule

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding:

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

	NDC
1	36800-542-15
2	36800-542-86

Label: CETIRIZINE HCL capsule

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding:

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

CETIRIZINE HCL capsule

Number of versions: 1

CETIRIZINE HCL capsule

CETIRIZINE HCL capsule

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CETIRIZINE HCL capsule

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.