Sda Laboratories - Cetirizine Hydrochloride Tablets - 10 Mg (66424-564)

Sda Laboratories - Cetirizine Hydrochloride Tablets - 10 Mg (66424-564)
SPL v6
SPL
SPL Set ID 222a7e77-33a6-44ca-9ab1-0bc4fc431aa3
Route
ORAL
Published
Effective Date 2021-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G4 Shape: rectangle Color: white Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2021-04-27
Description

CETIRIZINE HYDROCHLORIDE 10 MG

Purpose

ANTIHISTAMINE

Medication Information

Purpose

ANTIHISTAMINE

Description

CETIRIZINE HYDROCHLORIDE 10 MG

Use

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 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 51945-4

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.

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.

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.
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 toll free 1-800-687-0176

Mon – Fri 8 am to 5 pm

Other Information
  • store between 20º to 25ºC (68º and 77º F)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, titanium dioxide.

Active Ingredient (in Each Tablet)

CETIRIZINE HYDROCHLORIDE 10 MG

Structured Label Content

Use (USE)

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 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 51945-4 (51945-4)

Purpose (PURPOSE)

ANTIHISTAMINE

Warnings (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.

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.

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.
Directions (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? (QUESTIONS?)

call toll free 1-800-687-0176

Mon – Fri 8 am to 5 pm

Other Information (OTHER INFORMATION)
  • store between 20º to 25ºC (68º and 77º F)
Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, titanium dioxide.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

CETIRIZINE HYDROCHLORIDE 10 MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.689924 · Updated: 2026-03-14T23:02:21.986500