SPL v2
SPL
SPL Set ID 831d4141-b3be-4d98-a372-9c4d57ad296c
Route
ORAL
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Starch, Corn Lactose Monohydrate Povidone K29/32 Magnesium Stearate Hypromellose 2910 (5 Mpa.s) Titanium Dioxide Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: S;521 Shape: capsule Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-20
Description

Cetirizine Hydrochloride USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

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
Section 42229-5

This product is not manufactured or distributed by the owners of Zyrtec ®Tablets.

Distributed by:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Code: TN/Drugs/TN00002222/2006

L0001172

R1025

948006938

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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.
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.

Section 53414-9

If pregnant or breast-feeding:

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

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

store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments?

call toll-free 1-888-235-2466

Active Ingredient (in Each Tablet)

Cetirizine Hydrochloride USP, 10 mg

Package Label.principal Display Panel

'compare to the active ingredient in Zyrtec ®​ Allergy

a+health TM

original prescription strength

allergy relief

cetirizine HCl tablets USP, 10 mg

antihistamine

6 years and older

indoor & outdoor allergies

24 hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy, throat or nose

400 tablets

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)

This product is not manufactured or distributed by the owners of Zyrtec ®Tablets.

Distributed by:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Code: TN/Drugs/TN00002222/2006

L0001172

R1025

948006938

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

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.
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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

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)

store between 20° to 25°C (68° to 77°F).

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-235-2466

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

Cetirizine Hydrochloride USP, 10 mg

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

'compare to the active ingredient in Zyrtec ®​ Allergy

a+health TM

original prescription strength

allergy relief

cetirizine HCl tablets USP, 10 mg

antihistamine

6 years and older

indoor & outdoor allergies

24 hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy, throat or nose

400 tablets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.581839 · Updated: 2026-03-14T23:11:05.615438