SPL v1
SPL
SPL Set ID cbb270c3-34a4-4af8-9da0-2e545787cb55
Route
ORAL
Published
Effective Date 2025-06-05
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 Cellulose, Microcrystalline Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: G4 Shape: rectangle Color: white Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2025-05-01
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
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 toll-free 1-844-912-4012

Other Information
  • store between 20° to 25°C (68° to 77°F)
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
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 (1-800-222-1222) right away. 

Stop Use and Ask A Doctor If 

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

Cetirizine Hcl Tablets Usp 10 Mg

Drug Facts

Active Ingredient (in Each Tablet)

Cetirizine hydrochloride 10 mg

Principal Display Panel 14 Tablets

Principal Display Panel 35 Tablets

Principal Display Panel 90 Tablets

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.

Structured Label Content

Uses (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

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 toll-free 1-844-912-4012

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
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
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 (1-800-222-1222) right away. 

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.

Cetirizine Hcl Tablets Usp 10 Mg (Cetirizine HCl Tablets USP 10 mg)

Drug Facts

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

Cetirizine hydrochloride 10 mg

Principal Display Panel 14 Tablets (PRINCIPAL DISPLAY PANEL-14 Tablets)

Principal Display Panel 35 Tablets (PRINCIPAL DISPLAY PANEL-35 Tablets)

Principal Display Panel 90 Tablets (PRINCIPAL DISPLAY PANEL-90 Tablets)

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:15.210840 · Updated: 2026-03-14T23:08:56.104871