Cetirizine Hydrochloride Chewable Tablets

Cetirizine Hydrochloride Chewable Tablets
SPL v11
SPL
SPL Set ID a4758152-97dd-4a27-b4d9-11178654b93e
Route
ORAL
Published
Effective Date 2024-09-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Acesulfame Potassium Silicon Dioxide Sucrose Crospovidone Fd&c Blue No. 2 Fd&c Red No. 40 Guar Gum Magnesium Oxide Magnesium Stearate Mannitol Cellulose, Microcrystalline Starch, Corn Talc

Identifiers & Packaging

Pill Appearance
Imprint: 344 Shape: round Color: purple Size: 8 mm Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2011-09-09
Description

For 5 mg: Cetirizine hydrochloride, USP 5 mg For 10 mg: Cetirizine hydrochloride, USP 10 mg

Purpose

Antihistamine

Medication Information

Purpose


Antihistamine

Description

For 5 mg: Cetirizine hydrochloride, USP 5 mg For 10 mg: Cetirizine hydrochloride, 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
Warnings

Directions
  • may be taken with or without water
  • chew or crush tablets completely before swallowing

For 5 mg:



adults and children 6 years and over		 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over

 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

For 10 mg:

adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet

(10 mg) 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

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.

Questions?


Call toll free 1-800-818-4555 weekdays

Other Information


  • store between 20° to 25°C (68° to 77°F)
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date
Inactive Ingredients


acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

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 Doctor If


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

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)

If Pregnant Or Breast Feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Ask A Doctor Before Use If You Have


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

Package Label.principal Display Panel

For 5 mg Allergy:

Original Prescription Strength

NDC 47335-343-83

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor + Outdoor Allergies

Actual Size

Tutti-frutti Flavor

6 yrs & older

30 CHEWABLE TABLETS

SUN PHARMACEUTICAL INDUSTRIES LTD.

Ask A Doctor Or Pharmacist Before Use If


you are taking tranquilizers or sedatives.

Active Ingredient (in Each Chewable Tablet)

For 5 mg:Cetirizine hydrochloride, USP 5 mg



For 10 mg:Cetirizine hydrochloride, USP 10 mg

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
Purpose


Antihistamine

Warnings

Directions
  • may be taken with or without water
  • chew or crush tablets completely before swallowing

For 5 mg:



adults and children 6 years and over		 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over

 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

For 10 mg:

adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet

(10 mg) 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

Do Not Use (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.

Questions?


Call toll free 1-800-818-4555 weekdays

Other Information (Other information)


  • store between 20° to 25°C (68° to 77°F)
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date
Inactive Ingredients (Inactive ingredients)


acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

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 Doctor If (Stop use and ask doctor if)


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

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)

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

For 5 mg Allergy:

Original Prescription Strength

NDC 47335-343-83

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor + Outdoor Allergies

Actual Size

Tutti-frutti Flavor

6 yrs & older

30 CHEWABLE TABLETS

SUN PHARMACEUTICAL INDUSTRIES LTD.

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


you are taking tranquilizers or sedatives.

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

For 5 mg:Cetirizine hydrochloride, USP 5 mg



For 10 mg:Cetirizine hydrochloride, USP 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:35.717080 · Updated: 2026-03-14T23:03:46.018464