Zyrtec Allergy

Zyrtec Allergy
SPL v2
SPL
SPL Set ID a4146629-57f0-42e0-b905-df364a8a99f5
Route
ORAL
Published
Effective Date 2024-07-27
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: ZYRTEC;10;MG Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
NDA Active Since 2018-07-27

Description

Cetirizine HCl 10 mg 

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 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
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.

Drug Facts

Questions?

call 1-800-343-7805 (toll-free) or  215-273-8755 (collect)

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if pouch is torn or damaged
  • meets USP Dissolution Test 2
Package Labeling:

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
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.
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)

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg 

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

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

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.

Drug Facts

Questions?

call 1-800-343-7805 (toll-free) or  215-273-8755 (collect)

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if pouch is torn or damaged
  • meets USP Dissolution Test 2
Package Labeling:

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
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.

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 right away. (1-800-222-1222)

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

Cetirizine HCl 10 mg 

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)