Cetirizine Hydrochloride

Cetirizine Hydrochloride
SPL v3
SPL
SPL Set ID 4a8d2887-8ac3-4d54-9e67-4a271d416426
Route
ORAL
Published
Effective Date 2018-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: R152 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2007-12-27
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.

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 BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • 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
If Pregnant Or Breast Feeding
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

Principal Display Panel 14 Tablet Blister Pack Carton

COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC®*

Best

Choice®

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

Cetirizine HCl Tablets, USP 10 mg

ANTIHISTAMINE

24 Hour Allergy Relief

Indoor & Outdoor Allergies

Relief of:

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

14 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.

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 BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • 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
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 Tablet) (Active ingredient (in each tablet))

Cetirizine HCl, USP 10 mg

Principal Display Panel 14 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton)

COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC®*

Best

Choice®

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

Cetirizine HCl Tablets, USP 10 mg

ANTIHISTAMINE

24 Hour Allergy Relief

Indoor & Outdoor Allergies

Relief of:

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

14 TABLETS 10 mg Each

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.700954 · Updated: 2026-03-14T22:55:14.803903