DailyMed - ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

NDC Code(s): 50580-754-15, 50580-754-35
Packager: Kenvue Brands LLC

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

Drug Label Information

Updated June 5, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each tablet)
Cetirizine HCl 5 mg

Cetirizine HCl 5 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 ...

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 ■ 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)

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Directions

adults and children - 6 years and over - 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity - of symptoms; do not take more than 2 tablets (10mg ...

Other information
■ store between 20° to 25°C (68° to 77°F) ■ do not use if carton is opened. do not use if pouch is torn or damaged - ■ meets USP Dissolution Test 2

■ store between 20° to 25°C (68° to 77°F)
■ do not use if carton is opened. do not use if pouch is torn or damaged
■ meets USP Dissolution Test 2
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Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
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Questions?
call - 1-800-343-7805 (toll-free) or - 215-273-8755 (collect)

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
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PRINCIPAL DISPLAY PANEL
NDC 50580-754-15 - Zyrtec® ALLERGY - Cetirizine HCl Tablets - 5mg/antihistamine - 24 Hour relief of - Sneezing - Runny Nose - Itchy Throat or Nose - Itchy, Watery Eyes - 15 Tablets ...

NDC 50580-754-15

Zyrtec®

ALLERGY

Cetirizine HCl Tablets
5mg/antihistamine

24 Hour relief of
Sneezing

Runny Nose

Itchy Throat or Nose

Itchy, Watery Eyes

15 Tablets
5 mg each

Actual Size
Take 1 to 2 tablets* once daily depending on the severity of your symptoms
*Adults 65 and older take only one tablet per day

Indoor &
Outdoor
Allergies

5mg Strength Tablets

15
Tablets
5 mg
each

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INGREDIENTS AND APPEARANCE

Product Information

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adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Published Date (What is this?)	Version	Files
Jun 6, 2025	2 (current)	download
Feb 17, 2025	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1014676	cetirizine HCl 5 MG Oral Tablet	PSN
2	1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD
3	1014677	ZyrTEC 5 MG Oral Tablet	PSN
4	1014677	cetirizine hydrochloride 5 MG Oral Tablet [Zyrtec]	SBD
5	1014677	Zyrtec 5 MG Oral Tablet	SY
6	1014677	Zyrtec (cetirizine dihydrochloride 5 MG) Oral Tablet	SY

Label: ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

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	NDC
1	50580-754-15
2	50580-754-35

Label: ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

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ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

Number of versions: 2

ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

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ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

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