Cetirizine Hydrochloride

Cetirizine Hydrochloride
SPL v1
SPL
SPL Set ID f30900e6-425f-43e0-81b6-1fa3bd321f0b
Route
ORAL
Published
Effective Date 2018-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Povidone, Unspecified Lactose Monohydrate Magnesium Stearate Starch, Corn Talc Titanium Dioxide Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: RI52 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2012-11-01
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.

Section 53414-9

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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
Questions?

call 1-800-406-7984

Other Information
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25°C (68° to 77° F)
Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

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
Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton

Compare to the active

ingredient in Zyrtec® *

Marc's ®

Indoor/Outdoor

Original Prescription Strength

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg / Antihistamine

Allergy

24

Hour

Relief of:

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

30 TABLETS 10 mg EACH

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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
Questions?

call 1-800-406-7984

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25°C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

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

Cetirizine HCl, USP 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton)

Compare to the active

ingredient in Zyrtec® *

Marc's ®

Indoor/Outdoor

Original Prescription Strength

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg / Antihistamine

Allergy

24

Hour

Relief of:

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

30 TABLETS 10 mg EACH

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:35.463412 · Updated: 2026-03-14T22:55:09.496341