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
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Active Ingredient

Cetirizine HCl, USP 10 mg

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
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
  • 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

Description

Drug Facts

Questions?

call 1-800-406-7984

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.

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.
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

Active Ingredient (Active ingredient (in each tablet))

Cetirizine HCl, USP 10 mg

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
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)
  • 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

Questions?

call 1-800-406-7984

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.

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.
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

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Additional Information

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