Cetrizine Hydrochloride Tablets

Cetrizine Hydrochloride Tablets
SPL v4
SPL
SPL Set ID 84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a4
Route
ORAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2022-01-13
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Use(s)

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


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.

Active Ingredient

Cetirizine HCl 10 mg

Other Information

◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

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

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

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)

Cetirizine Hydrochloride Tablets

Drug Facts

Cetirizine Hydrochloride Tablet, Coated
Ask A Doctor Or Pharmacist Before Use If

taking tranquilizers or sedatives.

Structured Label Content

Use(s) (USE(S))

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 (PURPOSE)

Antihistamine

Storage (STORAGE)
  • store between 20° to 25°C (68° to 77°F)
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


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.

Active Ingredient

Cetirizine HCl 10 mg

Other Information (Other information)

◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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
Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

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

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)

Cetirizine Hydrochloride Tablets

Drug Facts

Cetirizine Hydrochloride Tablet, Coated (CETIRIZINE HYDROCHLORIDE TABLET, COATED)
Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

taking tranquilizers or sedatives.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:13.398006 · Updated: 2026-03-14T23:01:19.203951