Prv-1194a-2019-1030

Prv-1194a-2019-1030
SPL v3
SPL
SPL Set ID 5e0ef968-dff3-4446-8412-8085677332f0
Route
ORAL
Published
Effective Date 2019-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose Monohydrate Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Completed Since 2019-11-01 Until 2026-07-31
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Warnings and Precautions

Warnings

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 50566-9

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

Section 50567-7

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
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.

Directions
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 between 20 to 25°C (68 to 77°F)
  • retain carton for complete product information and warnings
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions Or Comments?

1-844-705-4384

Principal Display Panel

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC® ALLERGY†

2 Week Supply

24 Hour

ALLERGY RELIEF

Indoor & Outdoor Allergy Relief

Original Prescription Strength

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

For Relief of: • Sneezing   • Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Antihistamine

14 TABLETS

10 MG EACH 

ACTUAL SIZE

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)

Active Ingredient (in Each Tablet)

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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

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
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

Directions
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 (Other information)
  • store between 20 to 25°C (68 to 77°F)
  • retain carton for complete product information and warnings
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC® ALLERGY†

2 Week Supply

24 Hour

ALLERGY RELIEF

Indoor & Outdoor Allergy Relief

Original Prescription Strength

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

For Relief of: • Sneezing   • Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Antihistamine

14 TABLETS

10 MG EACH 

ACTUAL SIZE

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Keep Out of Reach of Children. (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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine HCl 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.746731 · Updated: 2026-03-14T23:03:59.769884