Zyrtec Allergy

Zyrtec Allergy
SPL v6
SPL
SPL Set ID 0face45c-af24-3559-e063-6294a90abde5
Route
ORAL
Published
Effective Date 2025-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Mannitol Polyethylene Glycol 400 Water Sodium Hydroxide Sorbitan Sorbitol Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance
Imprint: CZ10 Shape: oval Color: white Size: 13 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-15

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1

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.

Warnings

Warnings

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
Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information
  • store between 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
Inactive Ingredients

butylated hydroxytoluene, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Principal Display Panel

Original Prescription Strength

NDC 50580-786-13

ZYRTEC ®

ALLERGY

Cetirizine HCl capsules

10 mg/antihistamine

Indoor &

Outdoor

Allergies

Strength

10 mg Capsules

LIQUID GELS*

24 Hour relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

12 Liquid-Filled Capsules

10 mg each

Dye-Free

Actual Size

12 *LIQUID-FILLED

CAPSULES

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
If Pregnant Or Breast Feeding
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each Capsule)

Cetirizine HCl 10 mg


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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.

Purpose

Antihistamine

Warnings

Warnings

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
Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Original Prescription Strength

NDC 50580-786-13

ZYRTEC ®

ALLERGY

Cetirizine HCl capsules

10 mg/antihistamine

Indoor &

Outdoor

Allergies

Strength

10 mg Capsules

LIQUID GELS*

24 Hour relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

12 Liquid-Filled Capsules

10 mg each

Dye-Free

Actual Size

12 *LIQUID-FILLED

CAPSULES

When Using This Product (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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Cetirizine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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