Cetirizine Hydrochloride Tablets (allergy)

Cetirizine Hydrochloride Tablets (allergy)
SPL v1
SPL
SPL Set ID 89db2c96-62f6-4e75-8f0d-321b44094c60
Route
ORAL
Published
Effective Date 2025-04-28
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose 2910 (5 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: X;36 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-28

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

Warnings

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 1-855-274-4122



Distributed by:

Innovus Pharmaceuticals, Inc.

Reno, NV 89511

www.crclehealth.com



Made in India

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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.
Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

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 hydrochloride USP 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Package Label Principal Display Panel 10 Mg (365's Tablet Container Label)

*Compare to the

active ingredient

of Zyrtec®

Crcle

NDC 57483-190-14

Allergy Relief

Cetirizine Hydrochloride

Tablets USP, 10 mg

Antihistamine

Original Prescription Strength

INDOOR & OUTDOOR ALLERGIES

10 mg Strength Tablets

24

Hour

  Relief of

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

365 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

Purpose

Antihistamine

Warnings

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 1-855-274-4122



Distributed by:

Innovus Pharmaceuticals, Inc.

Reno, NV 89511

www.crclehealth.com



Made in India

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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

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 hydrochloride USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Package Label Principal Display Panel 10 Mg (365's Tablet Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (365's Tablet Container Label))

*Compare to the

active ingredient

of Zyrtec®

Crcle

NDC 57483-190-14

Allergy Relief

Cetirizine Hydrochloride

Tablets USP, 10 mg

Antihistamine

Original Prescription Strength

INDOOR & OUTDOOR ALLERGIES

10 mg Strength Tablets

24

Hour

  Relief of

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

365 TABLETS 10 mg each




Advanced Ingredient Data


Raw Label Data

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