Cetirizine Hydrochloride

Cetirizine Hydrochloride
SPL v1
SPL
SPL Set ID 1cfedef0-7cd3-8cd9-e063-6294a90a525d
Route
ORAL
Published
Effective Date 2021-05-21
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 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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not useif 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 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
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 10 Mg Tablet Bottle Label

NDC 51660-939-53

†Compare To

the active ingredient of

Zyrtec ®

ohm ®

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

24 Hour Relief of:

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

300 TABLETS

10 mg EACH

24

Hours

Original Prescription Strength

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 ifan 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 aretaking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not useif 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 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
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 10 Mg Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label)

NDC 51660-939-53

†Compare To

the active ingredient of

Zyrtec ®

ohm ®

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

24 Hour Relief of:

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

300 TABLETS

10 mg EACH

24

Hours

Original Prescription Strength

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.142875 · Updated: 2026-03-14T23:03:15.788850